<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/NCT03782480</url>
  </required_header>
  <id_info>
    <org_study_id>AGEC-10</org_study_id>
    <nct_id>NCT03782480</nct_id>
  </id_info>
  <brief_title>Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy</brief_title>
  <official_title>A Placebo-controlled Study Examining the Morphological/Biochemical Effects of Intrarosa on the Vulvar Vestibule and Vagina in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center for Vulvovaginal Disorders</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EndoCeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Center for Vulvovaginal Disorders</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The&#xD;
      clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor&#xD;
      all depend on androgens for normal function. In addition, the glands, which secrete&#xD;
      lubrication during sexual arousal, also require androgens to function. Deficiencies of both&#xD;
      estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of&#xD;
      these hormones lead to thinning in the tissues of the genital and urinary systems which have&#xD;
      been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently&#xD;
      complain of dryness and/or pain during sexual intercourse.&#xD;
&#xD;
      Historically, GSM treatment involved both androgens and estrogens, However, over the past few&#xD;
      decades estrogen based therapies have become much more common. More recently, clinical trials&#xD;
      have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in&#xD;
      menopausal women who have moderate to severe pain with intercourse.&#xD;
&#xD;
      Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug&#xD;
      Administration (FDA) used in women after menopause to treat moderate to severe pain during&#xD;
      sexual intercourse caused by changes in and around the vagina that happen with menopause.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tissues in the genitourinary system are both androgen- and estrogen-dependent. The clitoris,&#xD;
      vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor are&#xD;
      androgen-responsive. In addition, the minor vestibular glands and the major vestibular glands&#xD;
      (Bartholin's and Skene's) are androgen-dependent, mucin-secreting glands. Deficiencies of&#xD;
      both estrogens and androgens can occur both naturally during menopause or iatrogenically&#xD;
      because of certain medications (e.g. Depo Lupron, spironolactone) or surgically&#xD;
      (oophorectomy). Menopause-related deficiencies of these sex hormones lead to atrophic changes&#xD;
      in the genitourinary system which have been termed genitourinary syndrome of menopause (GSM).&#xD;
&#xD;
      While erythema is a nonspecific finding in atrophic tissue, focal painful erythema in the&#xD;
      androgen-dependent vestibule, particularly near the ostia of the Bartholin's glands (4:00 and&#xD;
      8:00 o'clock) and Skene's glands (1:00 and 11:00 o'clock) or lesser vestibular glands, is&#xD;
      highly suggestive of GSM. Patients with GSM will frequently complain of penetrative&#xD;
      dyspareunia and experience allodynia with the cotton swab palpation of the vulvar vestibule.&#xD;
      During examination of the vulvar vestibule, the examiner might note general pallor with&#xD;
      superimposed erythema. Physical exam can be improved by magnification (i.e. vulvoscopy).&#xD;
&#xD;
      Historically, GSM treatment involved both androgens and estrogens. However, in the absence of&#xD;
      information about intracrinology, over the past few decades, estradiol-based therapies have&#xD;
      been used exclusively. More recently, double-blind, placebo controlled clinical trials&#xD;
      demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in&#xD;
      postmenopausal women including moderate to severe dyspareunia. These trials have demonstrated&#xD;
      improvement in both subjective measures (such as improvement in dyspareunia) as well as&#xD;
      objective measurement of vaginal health (improved vaginal maturation index, decreased vaginal&#xD;
      pH) but they have not attempted to demonstrate improvement in the health of the vulvar&#xD;
      tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 2, 2019</start_date>
  <completion_date type="Anticipated">January 2, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2, 2021</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>Changes from baseline in morphological content of vulvar and vaginal cells</measure>
    <time_frame>2 years</time_frame>
    <description>Changes from baseline in density of androgen, estrogen and progesterone receptors. Unit of measure to be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in morphological content of vulvar and vaginal cells</measure>
    <time_frame>2 years</time_frame>
    <description>Changes from baseline in tissue steroid concentrations. Unit of measure to be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in morphological content of vulvar and vaginal cells</measure>
    <time_frame>2 years</time_frame>
    <description>Changes from baseline in blood steroid concentration. Unit of measure to be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in protein content of vulvar and vaginal cells</measure>
    <time_frame>2 years</time_frame>
    <description>Changes from baseline in mucin. Unit of measure to be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in enzymatic content of vulvar and vaginal cells</measure>
    <time_frame>2 years</time_frame>
    <description>Changes from baseline in enzymatic content (HSD17B5, HSD3B1, 5alphaRED2, aromatase, HDS17B1, sulfotransferase 2A1, sulfatase and UGT2B). All enzymes have the same unit of measure. Unit of measure to be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in antigen content of vulvar and vaginal cells</measure>
    <time_frame>2 years</time_frame>
    <description>Changes from baseline in PGP9.5. Unit of measure to be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in antigen content of vulvar and vaginal cells</measure>
    <time_frame>2 years</time_frame>
    <description>Changes from baseline in Ki-67 antigen. Unit of measure to be determined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in subject's scores on pain severity subscale VPAQ</measure>
    <time_frame>2 years</time_frame>
    <description>The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The pain severity subscale of the VPAQ consists of 3 pairs of verbal rating scale that test both pain intensity and pain affect. Each verbal rating scale is a 5-point scale with the following options: none=0, mild=1, moderate=2, severe=3, and worst possible=4. The calculated mean produces the overall score for the pain severity subscale ranging from 0-4 (4 is the worst score).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Menopause</condition>
  <condition>Genitourinary Syndrome of Menopause</condition>
  <condition>Vulvovaginal Atrophy</condition>
  <condition>Menopause Syndrome</condition>
  <condition>Dyspareunia</condition>
  <arm_group>
    <arm_group_label>Intrarosa</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily intravaginal administration at bedtime of one insert containing 6.5mg (0.50%) prasterone for 26 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily intravaginal administration at bedtime of one insert containing placebo for 26 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrarosa</intervention_name>
    <description>Prasterone intravaginal inserts</description>
    <arm_group_label>Intrarosa</arm_group_label>
    <other_name>prasterone</other_name>
    <other_name>Dehydroepiandrosterone</other_name>
    <other_name>DHEA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebo intravaginal inserts</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Postmenopausal women aged 40 to 80 years.&#xD;
&#xD;
          2. Women who have self-identified at screening pain at sexual activity as moderate to&#xD;
             severe and most bothersome symptom of vulvovaginal atrophy (Refer to Vaginal Atrophy&#xD;
             Symptoms Questionnaire (VASQ-MBS)).&#xD;
&#xD;
          3. Women having ≤5% of superficial cells on vaginal smear at screening.&#xD;
&#xD;
          4. Women having a vaginal pH above 5 at screening.&#xD;
&#xD;
          5. Willing to participate in the study and sign an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant metabolic or endocrine disease (including diabetes mellitus)&#xD;
             not controlled by medication.&#xD;
&#xD;
          2. Use of estrogen injectable drug therapy and/or progestin implant within 6 months prior&#xD;
             to screening visit.&#xD;
&#xD;
          3. Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy within 8&#xD;
             weeks prior to screening visit.&#xD;
&#xD;
          4. Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen&#xD;
             alone or estrogen/progestin products within 8 weeks prior to screening visit.&#xD;
&#xD;
          5. Previous treatment with androgens or anabolic steroids within 3 months prior to&#xD;
             screening visit (see Appendix 15.1 - Concomitant medications).&#xD;
&#xD;
          6. Confirmed clinically significant depression (not controlled by standard therapy) or&#xD;
             confirmed history of severe psychiatric disturbance.&#xD;
&#xD;
          7. The administration of any investigational drug within 30 days of screening visit.&#xD;
&#xD;
          8. Clinically significant abnormal serum biochemistry, urinalysis or hematology (as per&#xD;
             Investigator's assessment who should take into account the patient's pre-baseline&#xD;
             conditions).&#xD;
&#xD;
          9. Uterine palpable fibroids.&#xD;
&#xD;
         10. Uterine prolapse (when the cervix reaches labia minora at gynecologic exam).&#xD;
&#xD;
         11. Subjects who suffer from vulvar lichen sclerosus or any vulvar dermatological disorder&#xD;
             that affects the vulvar vestibule or vagina.&#xD;
&#xD;
         12. Chronic use of narcotics or alcoholism during the last 5 years.&#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>Fernand Labrie, MD</last_name>
    <role>Study Director</role>
    <affiliation>EndoCeutics Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leia Mitchell, MSc</last_name>
    <phone>2028870568</phone>
    <email>leiam.cvvd@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Leia Mitchell</last_name>
    <phone>2028870568</phone>
    <email>leiam.cvvd@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Centers for Vulvovaginal Disorders</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leia Mitchell, MSc</last_name>
      <phone>202-887-0568</phone>
      <email>leiam.cvvd@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Andrew T Goldstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sarah Cigna, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Centers for Vulvovaginal Disorders</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leia Mitchell, MSc</last_name>
      <phone>202-887-0568</phone>
      <email>leiam.cvvd@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Andrew T Goldstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Labrie F, Martel C, Pelletier G. Is vulvovaginal atrophy due to a lack of both estrogens and androgens? Menopause. 2017 Apr;24(4):452-461. doi: 10.1097/GME.0000000000000768.</citation>
    <PMID>27875388</PMID>
  </reference>
  <reference>
    <citation>Kingsberg S, Kellogg S, Krychman M. Treating dyspareunia caused by vaginal atrophy: a review of treatment options using vaginal estrogen therapy. Int J Womens Health. 2010 Aug 9;1:105-11. doi: 10.2147/ijwh.s4872.</citation>
    <PMID>21072280</PMID>
  </reference>
  <reference>
    <citation>Nappi RE, Palacios S. Impact of vulvovaginal atrophy on sexual health and quality of life at postmenopause. Climacteric. 2014 Feb;17(1):3-9. doi: 10.3109/13697137.2013.871696.</citation>
    <PMID>24423885</PMID>
  </reference>
  <reference>
    <citation>Labrie F. Intracrinology. Mol Cell Endocrinol. 1991 Jul;78(3):C113-8. doi: 10.1016/0303-7207(91)90116-a.</citation>
    <PMID>1838082</PMID>
  </reference>
  <reference>
    <citation>Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428.</citation>
    <PMID>25734980</PMID>
  </reference>
  <reference>
    <citation>Labrie F, 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; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.</citation>
    <PMID>26731686</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Center for Vulvovaginal Disorders</investigator_affiliation>
    <investigator_full_name>Andrew T. Goldstein, MD</investigator_full_name>
    <investigator_title>Study Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspareunia</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Atrophy</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 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/NCT03782480
org study id: AGEC-10
nct id: NCT03782480
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The
      clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor
      all depend on androgens for normal function. In addition, the glands, which secrete
      lubrication during sexual arousal, also require androgens to function. Deficiencies of both
      estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of
      these hormones lead to thinning in the tissues of the genital and urinary systems which have
      been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently
      complain of dryness and/or pain during sexual intercourse.

      Historically, GSM treatment involved both androgens and estrogens, However, over the past few
      decades estrogen based therapies have become much more common. More recently, clinical trials
      have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in
      menopausal women who have moderate to severe pain with intercourse.

      Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug
      Administration (FDA) used in women after menopause to treat moderate to severe pain during
      sexual intercourse caused by changes in and around the vagina that happen with menopause.
Tissues in the genitourinary system are both androgen- and estrogen-dependent. The clitoris,
      vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor are
      androgen-responsive. In addition, the minor vestibular glands and the major vestibular glands
      (Bartholin's and Skene's) are androgen-dependent, mucin-secreting glands. Deficiencies of
      both estrogens and androgens can occur both naturally during menopause or iatrogenically
      because of certain medications (e.g. Depo Lupron, spironolactone) or surgically
      (oophorectomy). Menopause-related deficiencies of these sex hormones lead to atrophic changes
      in the genitourinary system which have been termed genitourinary syndrome of menopause (GSM).

      While erythema is a nonspecific finding in atrophic tissue, focal painful erythema in the
      androgen-dependent vestibule, particularly near the ostia of the Bartholin's glands (4:00 and
      8:00 o'clock) and Skene's glands (1:00 and 11:00 o'clock) or lesser vestibular glands, is
      highly suggestive of GSM. Patients with GSM will frequently complain of penetrative
      dyspareunia and experience allodynia with the cotton swab palpation of the vulvar vestibule.
      During examination of the vulvar vestibule, the examiner might note general pallor with
      superimposed erythema. Physical exam can be improved by magnification (i.e. vulvoscopy).

      Historically, GSM treatment involved both androgens and estrogens. However, in the absence of
      information about intracrinology, over the past few decades, estradiol-based therapies have
      been used exclusively. More recently, double-blind, placebo controlled clinical trials
      demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in
      postmenopausal women including moderate to severe dyspareunia. These trials have demonstrated
      improvement in both subjective measures (such as improvement in dyspareunia) as well as
      objective measurement of vaginal health (improved vaginal maturation index, decreased vaginal
      pH) but they have not attempted to demonstrate improvement in the health of the vulvar
      tissue.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes from baseline in morphological content of vulvar and vaginal cells
time frame: 2 years
description: Changes from baseline in density of androgen, estrogen and progesterone receptors. Unit of measure to be determined.
measure: Changes from baseline in morphological content of vulvar and vaginal cells
time frame: 2 years
description: Changes from baseline in tissue steroid concentrations. Unit of measure to be determined.
measure: Changes from baseline in morphological content of vulvar and vaginal cells
time frame: 2 years
description: Changes from baseline in blood steroid concentration. Unit of measure to be determined.
measure: Changes from baseline in protein content of vulvar and vaginal cells
time frame: 2 years
description: Changes from baseline in mucin. Unit of measure to be determined.
measure: Changes from baseline in enzymatic content of vulvar and vaginal cells
time frame: 2 years
description: Changes from baseline in enzymatic content (HSD17B5, HSD3B1, 5alphaRED2, aromatase, HDS17B1, sulfotransferase 2A1, sulfatase and UGT2B). All enzymes have the same unit of measure. Unit of measure to be determined.
measure: Changes from baseline in antigen content of vulvar and vaginal cells
time frame: 2 years
description: Changes from baseline in PGP9.5. Unit of measure to be determined.
measure: Changes from baseline in antigen content of vulvar and vaginal cells
time frame: 2 years
description: Changes from baseline in Ki-67 antigen. Unit of measure to be determined.
measure: Mean change from baseline in subject's scores on pain severity subscale VPAQ
time frame: 2 years
description: The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The pain severity subscale of the VPAQ consists of 3 pairs of verbal rating scale that test both pain intensity and pain affect. Each verbal rating scale is a 5-point scale with the following options: none=0, mild=1, moderate=2, severe=3, and worst possible=4. The calculated mean produces the overall score for the pain severity subscale ranging from 0-4 (4 is the worst score).
arm group label: Intrarosa
arm group type: Active Comparator
description: Daily intravaginal administration at bedtime of one insert containing 6.5mg (0.50%) prasterone for 26 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Daily intravaginal administration at bedtime of one insert containing placebo for 26 weeks
intervention type: Drug
intervention name: Intrarosa
description: Prasterone intravaginal inserts
arm group label: Intrarosa
other name: prasterone
other name: Dehydroepiandrosterone
other name: DHEA
intervention type: Drug
intervention name: Placebos
description: Placebo intravaginal inserts
arm group label: Placebo
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Fernand Labrie, MD
role: Study Director
affiliation: EndoCeutics Inc.
last name: Leia Mitchell, MSc
phone: 2028870568
email: leiam.cvvd@gmail.com
last name: Leia Mitchell
phone: 2028870568
email: leiam.cvvd@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Labrie F, Martel C, Pelletier G. Is vulvovaginal atrophy due to a lack of both estrogens and androgens? Menopause. 2017 Apr;24(4):452-461. doi: 10.1097/GME.0000000000000768.
PMID: 27875388
citation: Kingsberg S, Kellogg S, Krychman M. Treating dyspareunia caused by vaginal atrophy: a review of treatment options using vaginal estrogen therapy. Int J Womens Health. 2010 Aug 9;1:105-11. doi: 10.2147/ijwh.s4872.
PMID: 21072280
citation: Nappi RE, Palacios S. Impact of vulvovaginal atrophy on sexual health and quality of life at postmenopause. Climacteric. 2014 Feb;17(1):3-9. doi: 10.3109/13697137.2013.871696.
PMID: 24423885
citation: Labrie F. Intracrinology. Mol Cell Endocrinol. 1991 Jul;78(3):C113-8. doi: 10.1016/0303-7207(91)90116-a.
PMID: 1838082
citation: Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428.
PMID: 25734980
citation: Labrie F, 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; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.
PMID: 26731686
responsible party type: Principal Investigator
investigator affiliation: Center for Vulvovaginal Disorders
investigator full name: Andrew T. Goldstein, MD
investigator title: Study Principle Investigator
mesh term: Dyspareunia
mesh term: Syndrome
mesh term: Atrophy
mesh term: Dehydroepiandrosterone
sharing ipd: No