<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01665170</url>
  </required_header>
  <id_info>
    <org_study_id>178 S11 PF</org_study_id>
    <secondary_id>2011-006129-17</secondary_id>
    <nct_id>NCT01665170</nct_id>
  </id_info>
  <brief_title>Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)</brief_title>
  <official_title>A Randomized, Double Blind, Placebo-controlled Pilot Study on the Efficacy of Passiflora Incarnata L. in an Acute Stressful Situation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pascoe Pharmazeutische Praeparate GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daacro</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pascoe Pharmazeutische Praeparate GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora&#xD;
      incarnata L. in an acute stressful situation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, double-blind, placebo-controlled, single-center study During Visit 1 study&#xD;
      information and an informed consent form are handed out. After study inclusion on Visit 2,&#xD;
      participants are assigned to one of two groups at random and receive the test products&#xD;
      (either Pascoflair® or placebo tablets). The 3rd visit includes the completion of&#xD;
      questionnaires regarding wellbeing and the Trier Social Stress Test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS Insecurity (During)</measure>
    <time_frame>during stress test = Visite 3</time_frame>
    <description>The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS Anxiety (During)</measure>
    <time_frame>during stress test = Visite 3</time_frame>
    <description>The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS Stress Perception (During)</measure>
    <time_frame>during stress test = Visite 3</time_frame>
    <description>The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Cortisol (Pre-post Comparison)</measure>
    <time_frame>1 day</time_frame>
    <description>2 min. prior to and 1 min. after the TSST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACTH (Pre-post Comparison)</measure>
    <time_frame>1 day</time_frame>
    <description>ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epinephrine (Before)</measure>
    <time_frame>1 day</time_frame>
    <description>2 min. prior the TSST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Norepinephrine (Before)</measure>
    <time_frame>before stress test</time_frame>
    <description>2 min. prior the TSST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State Anxiety (STAI-X1) Questionnaire</measure>
    <time_frame>1 day</time_frame>
    <description>The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = &quot;not at all&quot; to 4 = &quot;very true&quot;. The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POMS Questionnaire</measure>
    <time_frame>1 day</time_frame>
    <description>The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = &quot;not at all&quot; to 7 = &quot;very strongly&quot;. The questionnaire is completed on V2 and V3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MDBF Questionnaire</measure>
    <time_frame>1 day</time_frame>
    <description>The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = &quot;not at all&quot; to 5 = &quot;very true&quot;. To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3</measure>
    <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.&#xD;
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3</measure>
    <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3</measure>
    <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3</measure>
    <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3</measure>
    <time_frame>Visite 2, visite 3</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3</measure>
    <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3</measure>
    <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3</measure>
    <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3</measure>
    <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.&#xD;
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3</measure>
    <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
    <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Norepinephrine (After)</measure>
    <time_frame>1 day</time_frame>
    <description>2 min. after the TSST, higher value is better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)</measure>
    <time_frame>before TSST</time_frame>
    <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathovagal Balance (Before TSST, Standing - 2. Measurement)</measure>
    <time_frame>before TSST</time_frame>
    <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathovagal Balance (During TSST, Preparation - 3. Measurement)</measure>
    <time_frame>during TSST</time_frame>
    <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathovagal Balance (During TSST, Interview - 4. Measurement)</measure>
    <time_frame>during TSST</time_frame>
    <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)</measure>
    <time_frame>during TSST</time_frame>
    <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathovagal Balance (After TSST, Standing - 6. Measurement)</measure>
    <time_frame>after TSST</time_frame>
    <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathovagal Balance (After TSST, Sitting - 7. Measurement)</measure>
    <time_frame>after TSST</time_frame>
    <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Verum</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Verum arm - Pascoflair 425mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Passiflora incarnata</intervention_name>
    <description>3 x 1 tablet per day for 3 days</description>
    <arm_group_label>Verum</arm_group_label>
    <other_name>Pascoflair 425mg coated tablets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>3 x 1 ablet per day for 3 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide written informed consent;&#xD;
&#xD;
          -  Healthy male and female subjects&#xD;
&#xD;
          -  Non-smoker;&#xD;
&#xD;
          -  Age 25 to 45 years;&#xD;
&#xD;
          -  BMI ≥ 19 to ≤ 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any known allergies to the test substance;&#xD;
&#xD;
          -  Any known addiction to drugs, alcohol or positive results in the drug screening test;&#xD;
&#xD;
          -  Any serious general illness, ongoing or within the last 12 months;&#xD;
&#xD;
          -  Any febrile illness (&gt; 24 hrs.) within 7 days prior to treatment;&#xD;
&#xD;
          -  Any antibiotics for the last four weeks before study inclusion;&#xD;
&#xD;
          -  Diabetes mellitus;&#xD;
&#xD;
          -  Known heart disease, hypertension, kidney disease, significant respiratory disease,&#xD;
             epilepsy, or rheumatoid arthritis;&#xD;
&#xD;
          -  Known immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS)&#xD;
             which could place the subject at risk or interfere with the accuracy of the study&#xD;
             results;&#xD;
&#xD;
          -  Pregnancy or lactating;&#xD;
&#xD;
          -  Current participation or participation in any type of clinical study in the past week;&#xD;
&#xD;
          -  Current or past participation in a TSST study;&#xD;
&#xD;
          -  Employees of the Sponsor or the CRO;&#xD;
&#xD;
          -  Any other medication that, in the opinion of the Investigator is likely to affect&#xD;
             their response to treatment;&#xD;
&#xD;
          -  Clinically relevant abnormalities in physical examinations, vital signs, clinical&#xD;
             chemistry, or haematology as judged by the Investigator;&#xD;
&#xD;
          -  Any other condition the Investigator or their duly assigned representatives believes&#xD;
             may affect the ability of the individual to complete the study or the interpretation&#xD;
             of the study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Clemens, MD, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum Mutterhaus der Borromäerinnen GmbH, Feldstr. 16, 54290 Trier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Juliane Hellhammer</name>
      <address>
        <city>Trier</city>
        <zip>54296</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <results_first_submitted>June 12, 2013</results_first_submitted>
  <results_first_submitted_qc>November 4, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 9, 2015</results_first_posted>
  <last_update_submitted>November 4, 2015</last_update_submitted>
  <last_update_submitted_qc>November 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pascoflair</keyword>
  <keyword>tsst</keyword>
  <keyword>passiflora incarnata</keyword>
  <keyword>non smoking male</keyword>
  <keyword>and female volunteers</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Individuals will be recruited via newspaper, mailing lists and radio advertisement in the area of Trier,Germany by DAaCRO. Recruiting: May 2012 - July 2012 in medical center/ CRO for Trier Social Sress Tests.</recruitment_details>
      <pre_assignment_details>Three subjects were not included because the recruitment phase was already completed.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo arm, 3 x 1 tablet per every day for 3 days</description>
        </group>
        <group group_id="P2">
          <title>Verum</title>
          <description>Verum arm - Pascoflair 425mg, 3 x 1 tablet per every day for 3 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30">First patient in</participants>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Bevore TSST</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>During TSST</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>After TSST</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30">Last TSST/ last patient out</participants>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo arm</description>
        </group>
        <group group_id="B2">
          <title>Verum</title>
          <description>Verum arm - Pascoflair 425mg</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.57" spread="5.00"/>
                    <measurement group_id="B2" value="28.47" spread="5.81"/>
                    <measurement group_id="B3" value="28.5" spread="5.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>VAS Insecurity (During)</title>
        <description>The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.</description>
        <time_frame>during stress test = Visite 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>VAS Insecurity (During)</title>
          <description>The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.87" spread="30.92"/>
                    <measurement group_id="O2" value="60.93" spread="30.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>VAS Anxiety (During)</title>
        <description>The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.</description>
        <time_frame>during stress test = Visite 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
        </group_list>
        <measure>
          <title>VAS Anxiety (During)</title>
          <description>The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.67" spread="30.39"/>
                    <measurement group_id="O2" value="34.17" spread="30.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Cortisol (Pre-post Comparison)</title>
        <description>2 min. prior to and 1 min. after the TSST</description>
        <time_frame>1 day</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ACTH (Pre-post Comparison)</title>
        <description>ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST</description>
        <time_frame>1 day</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Epinephrine (Before)</title>
        <description>2 min. prior the TSST</description>
        <time_frame>1 day</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Norepinephrine (Before)</title>
        <description>2 min. prior the TSST</description>
        <time_frame>before stress test</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>Norepinephrine (Before)</title>
          <description>2 min. prior the TSST</description>
          <units>ng/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="430.29" spread="121.41"/>
                    <measurement group_id="O2" value="581.17" spread="160.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>State Anxiety (STAI-X1) Questionnaire</title>
        <description>The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = &quot;not at all&quot; to 4 = &quot;very true&quot;. The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3</description>
        <time_frame>1 day</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POMS Questionnaire</title>
        <description>The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = &quot;not at all&quot; to 7 = &quot;very strongly&quot;. The questionnaire is completed on V2 and V3.</description>
        <time_frame>1 day</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MDBF Questionnaire</title>
        <description>The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = &quot;not at all&quot; to 5 = &quot;very true&quot;. To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3</description>
        <time_frame>1 day</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.&#xD;
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
        <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.&#xD;
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.90" spread="24.23"/>
                    <measurement group_id="O2" value="11.21" spread="23.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>VAS Stress Perception (During)</title>
        <description>The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.</description>
        <time_frame>during stress test = Visite 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>VAS Stress Perception (During)</title>
          <description>The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.20" spread="28.77"/>
                    <measurement group_id="O2" value="57.3" spread="29.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
        <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="25.78"/>
                    <measurement group_id="O2" value="11.47" spread="26.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome.</description>
        <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.67" spread="24.75"/>
                    <measurement group_id="O2" value="-12.53" spread="23.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
        <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.53" spread="24.52"/>
                    <measurement group_id="O2" value="13.38" spread="26.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
        <time_frame>Visite 2, visite 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.47" spread="27.80"/>
                    <measurement group_id="O2" value="14.59" spread="28.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
        <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="28.30"/>
                    <measurement group_id="O2" value="10.28" spread="27.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
        <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.07" spread="28.28"/>
                    <measurement group_id="O2" value="1.00" spread="29.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
        <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.63" spread="26.58"/>
                    <measurement group_id="O2" value="17.17" spread="23.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.&#xD;
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
        <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.&#xD;
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.60" spread="32.92"/>
                    <measurement group_id="O2" value="19.17" spread="28.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3</title>
        <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome.</description>
        <time_frame>Visite 2 (before treatment), Visite 3 (after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3</title>
          <description>The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.&#xD;
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome.</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.40" spread="16.53"/>
                    <measurement group_id="O2" value="1.66" spread="13.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Norepinephrine (After)</title>
        <description>2 min. after the TSST, higher value is better</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>Norepinephrine (After)</title>
          <description>2 min. after the TSST, higher value is better</description>
          <units>ng/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="670.11" spread="204.61"/>
                    <measurement group_id="O2" value="803.14" spread="202.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)</title>
        <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
        <time_frame>before TSST</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)</title>
          <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
          <units>(low frequency/high frequency)*10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.22" spread="7.66"/>
                    <measurement group_id="O2" value="22.84" spread="9.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sympathovagal Balance (Before TSST, Standing - 2. Measurement)</title>
        <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
        <time_frame>before TSST</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>Sympathovagal Balance (Before TSST, Standing - 2. Measurement)</title>
          <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
          <units>(low frequency/high frequency)*10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.74" spread="11.05"/>
                    <measurement group_id="O2" value="33.14" spread="13.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sympathovagal Balance (During TSST, Preparation - 3. Measurement)</title>
        <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
        <time_frame>during TSST</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>Sympathovagal Balance (During TSST, Preparation - 3. Measurement)</title>
          <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
          <units>(low frequency/high frequency)*10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.23" spread="12.21"/>
                    <measurement group_id="O2" value="38.37" spread="16.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sympathovagal Balance (During TSST, Interview - 4. Measurement)</title>
        <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
        <time_frame>during TSST</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>Sympathovagal Balance (During TSST, Interview - 4. Measurement)</title>
          <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
          <units>(low frequency/high frequency)*10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.94" spread="13.94"/>
                    <measurement group_id="O2" value="39.25" spread="16.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)</title>
        <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
        <time_frame>during TSST</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)</title>
          <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
          <units>(low frequency/high frequency)*10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.01" spread="24.35"/>
                    <measurement group_id="O2" value="45.53" spread="20.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sympathovagal Balance (After TSST, Standing - 6. Measurement)</title>
        <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
        <time_frame>after TSST</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>Sympathovagal Balance (After TSST, Standing - 6. Measurement)</title>
          <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
          <units>(low frequency/high frequency)*10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.36" spread="21.23"/>
                    <measurement group_id="O2" value="43.28" spread="17.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sympathovagal Balance (After TSST, Sitting - 7. Measurement)</title>
        <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
        <time_frame>after TSST</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo arm</description>
          </group>
          <group group_id="O2">
            <title>Verum</title>
            <description>Verum arm - Pascoflair 425mg</description>
          </group>
        </group_list>
        <measure>
          <title>Sympathovagal Balance (After TSST, Sitting - 7. Measurement)</title>
          <description>Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.</description>
          <units>(low frequency/high frequency)*10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.42" spread="12.08"/>
                    <measurement group_id="O2" value="29.93" spread="13.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 days (during the intake of the medication)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo arm</description>
        </group>
        <group group_id="E2">
          <title>Verum</title>
          <description>Verum arm - Pascoflair 425mg</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Gabriele Weiß</name_or_title>
      <organization>PASCOE pharmazeutische Präparate GmbH</organization>
      <phone>0641-7960</phone>
      <email>klinischeforschung@pascoe.de</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01665170
org study id: 178 S11 PF
secondary id: 2011-006129-17
nct id: NCT01665170
lead sponsor: 
collaborator: 
has dmc: No
A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora
      incarnata L. in an acute stressful situation
Randomized, double-blind, placebo-controlled, single-center study During Visit 1 study
      information and an informed consent form are handed out. After study inclusion on Visit 2,
      participants are assigned to one of two groups at random and receive the test products
      (either Pascoflair® or placebo tablets). The 3rd visit includes the completion of
      questionnaires regarding wellbeing and the Trier Social Stress Test.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: VAS Insecurity (During)
time frame: during stress test = Visite 3
description: The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.
measure: VAS Anxiety (During)
time frame: during stress test = Visite 3
description: The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.
measure: VAS Stress Perception (During)
time frame: during stress test = Visite 3
description: The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.
measure: Serum Cortisol (Pre-post Comparison)
time frame: 1 day
description: 2 min. prior to and 1 min. after the TSST
measure: ACTH (Pre-post Comparison)
time frame: 1 day
description: ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST
measure: Epinephrine (Before)
time frame: 1 day
description: 2 min. prior the TSST
measure: Norepinephrine (Before)
time frame: before stress test
description: 2 min. prior the TSST
measure: State Anxiety (STAI-X1) Questionnaire
time frame: 1 day
description: The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = "not at all" to 4 = "very true". The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3
measure: POMS Questionnaire
time frame: 1 day
description: The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = "not at all" to 7 = "very strongly". The questionnaire is completed on V2 and V3.
measure: MDBF Questionnaire
time frame: 1 day
description: The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = "not at all" to 5 = "very true". To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3
measure: LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3
time frame: Visite 2 (before treatment), Visite 3 (after treatment)
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
measure: LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3
time frame: Visite 2 (before treatment), Visite 3 (after treatment)
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
measure: LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3
time frame: Visite 2 (before treatment), Visite 3 (after treatment)
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome.
measure: LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3
time frame: Visite 2 (before treatment), Visite 3 (after treatment)
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
measure: LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3
time frame: Visite 2, visite 3
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
measure: LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3
time frame: Visite 2 (before treatment), Visite 3 (after treatment)
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
measure: LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3
time frame: Visite 2 (before treatment), Visite 3 (after treatment)
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
measure: LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3
time frame: Visite 2 (before treatment), Visite 3 (after treatment)
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
measure: LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3
time frame: Visite 2 (before treatment), Visite 3 (after treatment)
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
measure: LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3
time frame: Visite 2 (before treatment), Visite 3 (after treatment)
description: The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome.
measure: Norepinephrine (After)
time frame: 1 day
description: 2 min. after the TSST, higher value is better
measure: Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)
time frame: before TSST
description: Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
measure: Sympathovagal Balance (Before TSST, Standing - 2. Measurement)
time frame: before TSST
description: Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
measure: Sympathovagal Balance (During TSST, Preparation - 3. Measurement)
time frame: during TSST
description: Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
measure: Sympathovagal Balance (During TSST, Interview - 4. Measurement)
time frame: during TSST
description: Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
measure: Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)
time frame: during TSST
description: Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
measure: Sympathovagal Balance (After TSST, Standing - 6. Measurement)
time frame: after TSST
description: Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
measure: Sympathovagal Balance (After TSST, Sitting - 7. Measurement)
time frame: after TSST
description: Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo arm
arm group label: Verum
arm group type: Active Comparator
description: Verum arm - Pascoflair 425mg
intervention type: Drug
intervention name: Passiflora incarnata
description: 3 x 1 tablet per day for 3 days
arm group label: Verum
other name: Pascoflair 425mg coated tablets
intervention type: Drug
intervention name: Placebo
description: 3 x 1 ablet per day for 3 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Clemens, MD, Prof
role: Principal Investigator
affiliation: Klinikum Mutterhaus der Borromäerinnen GmbH, Feldstr. 16, 54290 Trier
facility: 
country: Germany
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 