<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/NCT03298607</url>
  </required_header>
  <id_info>
    <org_study_id>H-17014613</org_study_id>
    <nct_id>NCT03298607</nct_id>
  </id_info>
  <brief_title>The Impact of Serelys PMS on Symptoms of PMS</brief_title>
  <official_title>The Impact of Sérélys PMS, a Herbal Remedy Based on Pollen Extraction and Saffron, on Symptoms of PMS: A Randomized, Double-blinded, Placebo Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jens Rikardt Andersen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Serelys Pharma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the present study is to better define and evaluate Serelys PMS in terms of&#xD;
      the impact on the different premenstrual syndrome (PMS) symptoms , tolerance, satisfaction&#xD;
      and overall quality of life of women with known discomforts during the premenstrual period.&#xD;
      The data from this study will be compared to data when the two different ingredients are&#xD;
      given as monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More than every other women aged 15 to 50 years of age have premenstrual symptoms such as&#xD;
      irritability, mood swings, fatigue, headaches, sleep disturbances, breast and abdominal pain,&#xD;
      bloating, water retention and weight gain. Some signs continue during menstruation. These&#xD;
      psychological and physical manifestations can make women vulnerable and have a negative&#xD;
      impact on their professional, social and sexual life. Randomized, double-blind,&#xD;
      placebo-controlled clinical studies demonstrated the beneficial effects of pollen extract in&#xD;
      premenstrual discomfort. The premenstrual period is probably caused by a change in the normal&#xD;
      amount of sex hormones which can induce disorders in the central neuroendocrine system and&#xD;
      estrogens are reported to reduce PMS symptoms to some extend. Moreover, it is well&#xD;
      established that serotonin may play a role in PMS, as some inhibitors of serotonin re-uptake&#xD;
      (SSRI) have an impact on premenstrual disorders. However, side effects may occur even when&#xD;
      using estrogens as well as SSRI. Recently the pollen extract formulation has been improved by&#xD;
      adding a natural extract of saffron. This latter component is known for its beneficial action&#xD;
      on maintaining comfort during the menstrual cycle of the woman and it especially supports&#xD;
      mood changes, one of the mayor PMS symptoms. The effect of Safran was studied more&#xD;
      specifically in a randomized controlled double-blind, placebo-controlled clinical trial in&#xD;
      women with premenstrual discomfort. This study showed a progressive and significant&#xD;
      improvement after the use of saffron. In an other study saffron was documented to improve&#xD;
      mood in patients with milder depression.&#xD;
&#xD;
      In summary, the components of saffron helps to improve the well-being of women during the&#xD;
      premenstrual and menstrual period and have a well documented impact on mood. The pollen based&#xD;
      extracts have well documented impact on most of PMS symptoms but possibly lesser on mood&#xD;
      changes, which is also one of the mayor symptoms of PMS. The mechanisms by which saffron and&#xD;
      pollen based extraction works is expected to be different and an additive impact is expected.&#xD;
      The investigation is initiated by the researchers who feel that in PMS an alternatives to&#xD;
      SSRI and estrogen treatment is needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</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>Parallel Assignment</intervention_model>
    <intervention_model_description>2 months treatment with (Food Supplement - Serelys PMS)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Placebo controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>PMS symptoms evaluation - Premenstrual Tension</measure>
    <time_frame>2 months</time_frame>
    <description>Premenstrual Tension Scale (PMTS) - Self-rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PMS symptoms evaluation - Premenstrual Tension 2</measure>
    <time_frame>2 months</time_frame>
    <description>Premenstrual Tension Scale (PMTS) - Observe Rating Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PMS symptoms evaluation - premenstrual discomfort</measure>
    <time_frame>2 months</time_frame>
    <description>Evaluation of premenstrual discomfort by Visual Analog Scales (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effect registration</measure>
    <time_frame>2 months</time_frame>
    <description>Tolerance will be assessed through a scoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction scored by the patients</measure>
    <time_frame>2 months</time_frame>
    <description>Satisfaction and well-being will be assessed through a scoring system</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Premenstrual Syndrome</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 capsules daily for 2 months containing inactive substances</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serelys PMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 capsules daily for 2 months containing pollen extract</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 months treatment</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Serelys PMS</intervention_name>
    <description>2 months treatment</description>
    <arm_group_label>Serelys PMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least five inconveniences in the premenstrual period and which disappear quickly&#xD;
             with the end of menstruation : Irritability, Tension, Fatigue, Dysphoria (sadness),&#xD;
             Reduced motor coordination, Difficulty concentrating, Changes in libido, Changes in&#xD;
             appetite.&#xD;
&#xD;
          -  these inconveniences disappear quickly with the end of menstruation&#xD;
&#xD;
          -  At least one of these criteria must be present in the premenstrual and menstrual&#xD;
             period:&#xD;
&#xD;
               1. Deterioration in relations with the family, at home, in school or at work&#xD;
&#xD;
               2. Having thought to take painkillers for at least one menstrual cycle.&#xD;
&#xD;
          -  Have symptoms of dysphoria / premenstrual sadness at least during the previous 6&#xD;
             cycles.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to any component of the product and known renal and hepatic impairment.&#xD;
&#xD;
          -  Existence of major evolving pathologies&#xD;
&#xD;
          -  Convulsions. Existence of psychiatric disorders, cravings&#xD;
&#xD;
          -  Suicidal thoughts&#xD;
&#xD;
          -  Taking medications that may interfere with PMS symptoms like eg estrogens.&#xD;
&#xD;
          -  Participation in another clinical study at the same time.&#xD;
&#xD;
          -  Pregnancy and / or lactation;&#xD;
&#xD;
          -  Difficulties to collaborate and difficulties to understand and complete the&#xD;
             questionnaires.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaj Winther Hansen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>UCopenhagen, Department of Nutrition, Exercise and Sport</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition, Exercise and Sports, University of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>1958FC</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>October 12, 2018</last_update_submitted>
  <last_update_submitted_qc>October 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Jens Rikardt Andersen</investigator_full_name>
    <investigator_title>Adj Professor, Department of Nutrition, Exercise and Sports</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premenstrual Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03298607
org study id: H-17014613
nct id: NCT03298607
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the present study is to better define and evaluate Serelys PMS in terms of
      the impact on the different premenstrual syndrome (PMS) symptoms , tolerance, satisfaction
      and overall quality of life of women with known discomforts during the premenstrual period.
      The data from this study will be compared to data when the two different ingredients are
      given as monotherapy.
More than every other women aged 15 to 50 years of age have premenstrual symptoms such as
      irritability, mood swings, fatigue, headaches, sleep disturbances, breast and abdominal pain,
      bloating, water retention and weight gain. Some signs continue during menstruation. These
      psychological and physical manifestations can make women vulnerable and have a negative
      impact on their professional, social and sexual life. Randomized, double-blind,
      placebo-controlled clinical studies demonstrated the beneficial effects of pollen extract in
      premenstrual discomfort. The premenstrual period is probably caused by a change in the normal
      amount of sex hormones which can induce disorders in the central neuroendocrine system and
      estrogens are reported to reduce PMS symptoms to some extend. Moreover, it is well
      established that serotonin may play a role in PMS, as some inhibitors of serotonin re-uptake
      (SSRI) have an impact on premenstrual disorders. However, side effects may occur even when
      using estrogens as well as SSRI. Recently the pollen extract formulation has been improved by
      adding a natural extract of saffron. This latter component is known for its beneficial action
      on maintaining comfort during the menstrual cycle of the woman and it especially supports
      mood changes, one of the mayor PMS symptoms. The effect of Safran was studied more
      specifically in a randomized controlled double-blind, placebo-controlled clinical trial in
      women with premenstrual discomfort. This study showed a progressive and significant
      improvement after the use of saffron. In an other study saffron was documented to improve
      mood in patients with milder depression.

      In summary, the components of saffron helps to improve the well-being of women during the
      premenstrual and menstrual period and have a well documented impact on mood. The pollen based
      extracts have well documented impact on most of PMS symptoms but possibly lesser on mood
      changes, which is also one of the mayor symptoms of PMS. The mechanisms by which saffron and
      pollen based extraction works is expected to be different and an additive impact is expected.
      The investigation is initiated by the researchers who feel that in PMS an alternatives to
      SSRI and estrogen treatment is needed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 months treatment with (Food Supplement - Serelys PMS)
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Placebo controlled
measure: PMS symptoms evaluation - Premenstrual Tension
time frame: 2 months
description: Premenstrual Tension Scale (PMTS) - Self-rating scale
measure: PMS symptoms evaluation - Premenstrual Tension 2
time frame: 2 months
description: Premenstrual Tension Scale (PMTS) - Observe Rating Scale
measure: PMS symptoms evaluation - premenstrual discomfort
time frame: 2 months
description: Evaluation of premenstrual discomfort by Visual Analog Scales (VAS)
measure: Side effect registration
time frame: 2 months
description: Tolerance will be assessed through a scoring system
measure: Satisfaction scored by the patients
time frame: 2 months
description: Satisfaction and well-being will be assessed through a scoring system
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 capsules daily for 2 months containing inactive substances
arm group label: Serelys PMS
arm group type: Active Comparator
description: 2 capsules daily for 2 months containing pollen extract
intervention type: Dietary Supplement
intervention name: Placebo
description: 2 months treatment
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Serelys PMS
description: 2 months treatment
arm group label: Serelys PMS
criteria: 
gender: Female
gender based: Yes
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kaj Winther Hansen, MD
role: Study Chair
affiliation: UCopenhagen, Department of Nutrition, Exercise and Sport
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Jens Rikardt Andersen
investigator title: Adj Professor, Department of Nutrition, Exercise and Sports
mesh term: Premenstrual Syndrome
sharing ipd: No