<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/NCT02229721</url>
  </required_header>
  <id_info>
    <org_study_id>2011-001310-34</org_study_id>
    <nct_id>NCT02229721</nct_id>
  </id_info>
  <brief_title>Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women</brief_title>
  <official_title>Female Sexual Dysfunction in the Menopause: Effect of Intranasal Oxytocin Administration on Sexual Function and Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leadiant Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether intranasal oxytocin is effective in&#xD;
      comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal&#xD;
      women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Female Sexual Function</measure>
    <time_frame>22 weeks</time_frame>
    <description>Assessment by standardized questionnaires including Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), Sexual Quality of Life-Female (SQOL-F), Sexual Activity Record (SAR), and Sexual Interest and Desire Inventory-Female (SIDI-F).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Scale (HDS)</measure>
    <time_frame>22 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Female Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>Syntocinon Nasalspray 32 IU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.&#xD;
The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Nasalspray</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.&#xD;
The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Syntocinon Nasalspray</intervention_name>
    <description>Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.&#xD;
The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.</description>
    <arm_group_label>Placebo Nasalspray</arm_group_label>
    <arm_group_label>Syntocinon Nasalspray 32 IU</arm_group_label>
    <other_name>Oxytocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Nasalspray</intervention_name>
    <description>Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.&#xD;
The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.</description>
    <arm_group_label>Placebo Nasalspray</arm_group_label>
    <arm_group_label>Syntocinon Nasalspray 32 IU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to attempt sexual intercourse and/ or masturbation at least two times per&#xD;
             week&#xD;
&#xD;
          -  Ongoing relationship for at least 3 months&#xD;
&#xD;
          -  Female subjects aging 40 years and more, Male subjects must be older than 18&#xD;
&#xD;
          -  The participation in this study should be of free choice to male partners&#xD;
&#xD;
          -  Willingness to perform a pregnancy test every month (for pre-menopausal subjects)&#xD;
&#xD;
          -  Willingness to use contraception during the study period (for pre-menopausal subjects)&#xD;
&#xD;
          -  Normal findings in the urogenital tract unless the investigator considers an&#xD;
             abnormality to be clinically irrelevant&#xD;
&#xD;
          -  Normal laboratory values unless the investigator considers an abnormality to be&#xD;
             clinically irrelevant&#xD;
&#xD;
          -  Normal findings in the medical history and physical examination unless the&#xD;
             investigator considers an abnormality to be clinically irrelevant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary sexual dysfunction&#xD;
&#xD;
          -  sexual abuse&#xD;
&#xD;
          -  severe psychiatric diseases&#xD;
&#xD;
          -  untreated conditions and medication intake with associated reduction of sexual&#xD;
             function.&#xD;
&#xD;
          -  In male partners: any severe andrological or related medical problem.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Dana Muin</investigator_full_name>
    <investigator_title>Univ. Prof. Michaela Bayerle-Eder</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02229721
org study id: 2011-001310-34
nct id: NCT02229721
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether intranasal oxytocin is effective in
      comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal
      women.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Female Sexual Function
time frame: 22 weeks
description: Assessment by standardized questionnaires including Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), Sexual Quality of Life-Female (SQOL-F), Sexual Activity Record (SAR), and Sexual Interest and Desire Inventory-Female (SIDI-F).
measure: Hamilton Depression Scale (HDS)
time frame: 22 weeks
arm group label: Syntocinon Nasalspray 32 IU
arm group type: Active Comparator
description: Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
arm group label: Placebo Nasalspray
arm group type: Placebo Comparator
description: Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
intervention type: Drug
intervention name: Syntocinon Nasalspray
description: Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
arm group label: Placebo Nasalspray
arm group label: Syntocinon Nasalspray 32 IU
other name: Oxytocin
intervention type: Drug
intervention name: Placebo Nasalspray
description: Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
arm group label: Placebo Nasalspray
arm group label: Syntocinon Nasalspray 32 IU
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Dana Muin
investigator title: Univ. Prof. Michaela Bayerle-Eder
mesh term: Oxytocin