<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/NCT02968342</url>
  </required_header>
  <id_info>
    <org_study_id>18.11.2015-21/35</org_study_id>
    <nct_id>NCT02968342</nct_id>
  </id_info>
  <brief_title>Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women</brief_title>
  <official_title>Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is the role of vaginal progesterone gel in the treatment of&#xD;
      menopausal hypoactive sexual desire disorder. Half of the study participants will receive a&#xD;
      standard dose of self applied vaginal progesterone gel and the other half will receive oral&#xD;
      vitamin tablets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Steroid hormones play fundamental roles in sexual behaviour. Sexual activity is related to&#xD;
      hormone concentrations and ovulation in women. Women's sexuality, unlike that of most&#xD;
      mammals, is not solely defined by sexual receptivity during the short window of fertility.&#xD;
      Women are also prone to initiate luteal-phase sex when serum levels of progesterone are&#xD;
      highest in the menstrual cycle.As a result of ovarian hormonal cessation after menopause&#xD;
      women may face alterations in sexual desire.&#xD;
&#xD;
      The role of progesterone supplementation in improving sexual desire in the menopausal period&#xD;
      is investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FSFI (Female Sexual Function Index) questionnaire &quot;arousal&quot; domain</measure>
    <time_frame>1 month</time_frame>
    <description>Increment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FSFI (Female Sexual Function Index) questionnaire &quot;lubrication&quot; domain</measure>
    <time_frame>1 month</time_frame>
    <description>Increment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FSFI (Female Sexual Function Index) questionnaire all domains</measure>
    <time_frame>1 month</time_frame>
    <description>Increment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FSDS-R (Female Sexual Distress Scale- Revised) score</measure>
    <time_frame>1 month</time_frame>
    <description>Decline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Menopause</condition>
  <condition>Sexual Desire Disorder</condition>
  <condition>Hypoactive Sexual Desire Disorder</condition>
  <arm_group>
    <arm_group_label>Vaginal progesterone 8%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vaginal progesterone application 8%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral multivitamin supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vaginal progesterone 8%</intervention_name>
    <description>vaginal self application</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Vaginal progesterone 8%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Menopausal status&#xD;
&#xD;
          -  Sexually active&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history of chronic psychiatric disease&#xD;
&#xD;
          -  Medical conditions associated with female sexual dysfunction; cardiovascular disease,&#xD;
             uncontrolled chronic HT (hypertension) ,DM (diabetes mellitus), History of gynecologic&#xD;
             surgery, female gynecological cancer ( breast, ovarian, uterine, cervical)&#xD;
&#xD;
          -  Medications associated with female sexual dysfunction; Antidepressants opiates, beta&#xD;
             blockers, Antiepileptics ( gabapentin, topiramate,phenytoin) benzodiazepines&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serdar G Aydin, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bezmialem Üniversitesi Tıp Fakültesi Hastanesi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ayşe G Karasu, M.D</last_name>
    <phone>5365144142</phone>
    <email>agokmenkarasu@bezmialem.edu.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bezmialem Vakif University</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ayşe F Karasu</last_name>
      <phone>5365144142</phone>
      <email>agokmenkarasu@bezmialem.edu.tr</email>
    </contact>
    <contact_backup>
      <last_name>Ayşe F Karasu, Türkiye</last_name>
      <phone>5365144142</phone>
      <phone_ext>Karasu</phone_ext>
      <email>agokmenkarasu@bezmialem.edu.tr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Prasad A, Mumford SL, Buck Louis GM, Ahrens KA, Sjaarda LA, Schliep KC, Perkins NJ, Kissell KA, Wactawski-Wende J, Schisterman EF. Sexual activity, endogenous reproductive hormones and ovulation in premenopausal women. Horm Behav. 2014 Jul;66(2):330-8. doi: 10.1016/j.yhbeh.2014.06.012. Epub 2014 Jun 20.</citation>
    <PMID>24954690</PMID>
  </reference>
  <reference>
    <citation>Brown SG, Calibuso MJ, Roedl AL. Women's sexuality, well-being, and the menstrual cycle: methodological issues and their interrelationships. Arch Sex Behav. 2011 Aug;40(4):755-65. doi: 10.1007/s10508-010-9630-3. Epub 2010 May 13.</citation>
    <PMID>20464468</PMID>
  </reference>
  <reference>
    <citation>Gangestad SW, Thornhill R. Human oestrus. Proc Biol Sci. 2008 May 7;275(1638):991-1000. doi: 10.1098/rspb.2007.1425.</citation>
    <PMID>18252670</PMID>
  </reference>
  <reference>
    <citation>Grebe NM, Gangestad SW, Garver-Apgar CE, Thornhill R. Women's luteal-phase sexual proceptivity and the functions of extended sexuality. Psychol Sci. 2013 Oct;24(10):2106-10. doi: 10.1177/0956797613485965. Epub 2013 Aug 21.</citation>
    <PMID>23965377</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>October 19, 2017</last_update_submitted>
  <last_update_submitted_qc>October 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypoactive sexual desire disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypokinesia</mesh_term>
    <mesh_term>Sexual Dysfunctions, Psychological</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02968342
org study id: 18.11.2015-21/35
nct id: NCT02968342
lead sponsor: 
has dmc: Yes
The objective of this study is the role of vaginal progesterone gel in the treatment of
      menopausal hypoactive sexual desire disorder. Half of the study participants will receive a
      standard dose of self applied vaginal progesterone gel and the other half will receive oral
      vitamin tablets.
Steroid hormones play fundamental roles in sexual behaviour. Sexual activity is related to
      hormone concentrations and ovulation in women. Women's sexuality, unlike that of most
      mammals, is not solely defined by sexual receptivity during the short window of fertility.
      Women are also prone to initiate luteal-phase sex when serum levels of progesterone are
      highest in the menstrual cycle.As a result of ovarian hormonal cessation after menopause
      women may face alterations in sexual desire.

      The role of progesterone supplementation in improving sexual desire in the menopausal period
      is investigated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: FSFI (Female Sexual Function Index) questionnaire "arousal" domain
time frame: 1 month
description: Increment
measure: FSFI (Female Sexual Function Index) questionnaire "lubrication" domain
time frame: 1 month
description: Increment
measure: FSFI (Female Sexual Function Index) questionnaire all domains
time frame: 1 month
description: Increment
measure: FSDS-R (Female Sexual Distress Scale- Revised) score
time frame: 1 month
description: Decline
arm group label: Vaginal progesterone 8%
arm group type: Experimental
description: Vaginal progesterone application 8%
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral multivitamin supplement
intervention type: Device
intervention name: Vaginal progesterone 8%
description: vaginal self application
arm group label: Placebo
arm group label: Vaginal progesterone 8%
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Serdar G Aydin, M.D
role: Principal Investigator
affiliation: Bezmialem Üniversitesi Tıp Fakültesi Hastanesi
last name: Ayşe G Karasu, M.D
phone: 5365144142
email: agokmenkarasu@bezmialem.edu.tr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
citation: Prasad A, Mumford SL, Buck Louis GM, Ahrens KA, Sjaarda LA, Schliep KC, Perkins NJ, Kissell KA, Wactawski-Wende J, Schisterman EF. Sexual activity, endogenous reproductive hormones and ovulation in premenopausal women. Horm Behav. 2014 Jul;66(2):330-8. doi: 10.1016/j.yhbeh.2014.06.012. Epub 2014 Jun 20.
PMID: 24954690
citation: Brown SG, Calibuso MJ, Roedl AL. Women's sexuality, well-being, and the menstrual cycle: methodological issues and their interrelationships. Arch Sex Behav. 2011 Aug;40(4):755-65. doi: 10.1007/s10508-010-9630-3. Epub 2010 May 13.
PMID: 20464468
citation: Gangestad SW, Thornhill R. Human oestrus. Proc Biol Sci. 2008 May 7;275(1638):991-1000. doi: 10.1098/rspb.2007.1425.
PMID: 18252670
citation: Grebe NM, Gangestad SW, Garver-Apgar CE, Thornhill R. Women's luteal-phase sexual proceptivity and the functions of extended sexuality. Psychol Sci. 2013 Oct;24(10):2106-10. doi: 10.1177/0956797613485965. Epub 2013 Aug 21.
PMID: 23965377
responsible party type: Sponsor
mesh term: Hypokinesia
mesh term: Sexual Dysfunctions, Psychological
mesh term: Progesterone
sharing ipd: Undecided