<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/NCT03287232</url>
  </required_header>
  <id_info>
    <org_study_id>ERC-242</org_study_id>
    <nct_id>NCT03287232</nct_id>
  </id_info>
  <brief_title>Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)</brief_title>
  <official_title>Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EndoCeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EndoCeutics Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on&#xD;
      Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">July 22, 2019</completion_date>
  <primary_completion_date type="Actual">March 8, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sexual desire</measure>
    <time_frame>28 weeks</time_frame>
    <description>Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 &amp; 2).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distress from low sexual desire</measure>
    <time_frame>28 weeks</time_frame>
    <description>Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfying sexual events (SSEs)</measure>
    <time_frame>28 weeks</time_frame>
    <description>Change from Baseline in the number of SSEs from a daily log of sexual activity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">653</enrollment>
  <condition>Hypoactive Sexual Desire Disorder</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Prasterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Vaginal Insert</intervention_name>
    <description>Daily administration of a placebo vaginal insert.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prasterone 6.5 mg (0.50%) Vaginal Insert</intervention_name>
    <description>Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.</description>
    <arm_group_label>Prasterone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (main criteria):&#xD;
&#xD;
          -  Postmenopausal women (hysterectomized or not).&#xD;
&#xD;
          -  Women between 40 and 80 years of age.&#xD;
&#xD;
          -  Being in a stable relationship with the opportunity for sexual activity or&#xD;
             masturbation at least once a month during the last 6 months or longer (before&#xD;
             screening visit) and during the following 8 months.&#xD;
&#xD;
          -  Diagnosis of HSDD confirmed by a qualified clinician.&#xD;
&#xD;
          -  Willing to participate in the study and sign an informed consent.&#xD;
&#xD;
        Exclusion Criteria (main criteria):&#xD;
&#xD;
          -  Chronic or acute life stress or major life change that could have interfered and&#xD;
             continues to interfere significantly with sexual activity.&#xD;
&#xD;
          -  Taking drugs which could be responsible for HSDD.&#xD;
&#xD;
          -  Severe medical condition which can explain the loss of sexual desire.&#xD;
&#xD;
          -  The administration of any investigational drug within 30 days of screening visit.&#xD;
&#xD;
          -  Clinically significant abnormal serum biochemistry, urinalysis or hematology.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claude Labrie, M.D., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>EndoCeutics Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leonard R. Derogatis, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maryland Center for Sexual Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endoceutics site # 106</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 104</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 117</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 108</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>84704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 121</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site #128</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 30</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 17</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 36</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 52</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 125</name>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <zip>06320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 7</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 95</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 120</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 99</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 26</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 60</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site #118</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 54</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 92</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 114</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 105</name>
      <address>
        <city>Sanford</city>
        <state>Florida</state>
        <zip>32771</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 89</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 80</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 90</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 107</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 119</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 23</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 91</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 111</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 55</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 88</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 86</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 103</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 22</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 123</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 101</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 50</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 44</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 81</name>
      <address>
        <city>Plainsboro</city>
        <state>New Jersey</state>
        <zip>08536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 20</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 110</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 97</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 58</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 115</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 116</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 100</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 5</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 93</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 75</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 127</name>
      <address>
        <city>Bluffton</city>
        <state>South Carolina</state>
        <zip>29910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 126</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 112</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 94</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 64</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site #124</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site #122</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 82</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 102</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 96</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 3</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 98</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 76</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 68</name>
      <address>
        <city>Sarnia</city>
        <state>Ontario</state>
        <zip>N7T 4X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 18</name>
      <address>
        <city>Lévis</city>
        <state>Quebec</state>
        <zip>G6W 0M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 02</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1S 2L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 77</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1W 4R4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 78</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G3K 2P8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoceutics site # 11</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1L 0H8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6.</citation>
    <PMID>19424093</PMID>
  </reference>
  <reference>
    <citation>Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.</citation>
    <PMID>26597311</PMID>
  </reference>
  <reference>
    <citation>Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.</citation>
    <PMID>26725467</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <disposition_first_submitted>July 29, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>July 29, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 3, 2020</disposition_first_posted>
  <last_update_submitted>April 7, 2021</last_update_submitted>
  <last_update_submitted_qc>April 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prasterone</keyword>
  <keyword>DHEA</keyword>
  <keyword>Menopause</keyword>
  <keyword>Sexual 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>Dehydroepiandrosterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03287232
org study id: ERC-242
nct id: NCT03287232
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on
      Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Sexual desire
time frame: 28 weeks
description: Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).
measure: Distress from low sexual desire
time frame: 28 weeks
description: Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
measure: Satisfying sexual events (SSEs)
time frame: 28 weeks
description: Change from Baseline in the number of SSEs from a daily log of sexual activity.
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Prasterone
arm group type: Experimental
intervention type: Drug
intervention name: Placebo Vaginal Insert
description: Daily administration of a placebo vaginal insert.
arm group label: Placebo
intervention type: Drug
intervention name: Prasterone 6.5 mg (0.50%) Vaginal Insert
description: Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
arm group label: Prasterone
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Claude Labrie, M.D., Ph.D.
role: Study Chair
affiliation: EndoCeutics Inc.
last name: Leonard R. Derogatis, Ph.D.
role: Principal Investigator
affiliation: Maryland Center for Sexual Health
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country: Canada
country: United States
citation: Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6.
PMID: 19424093
citation: Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.
PMID: 26597311
citation: Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.
PMID: 26725467
responsible party type: Sponsor
mesh term: Hypokinesia
mesh term: Sexual Dysfunctions, Psychological
mesh term: Dehydroepiandrosterone
sharing ipd: No