Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia
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|ClinicalTrials.gov Identifier: NCT03568604|
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dyspareunia||Drug: Prasterone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label study of daily administration of 6.5 mg prasterone, approved for moderate to severe dyspareunia for vaginal atrophy in menopausal women, to see if there are changes to the vulva, vestibule, urethral meatus and vagina on vulvoscopy after 20 weeks|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Vulvoscopy Photography Study of Changes in Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Administration of 6.5 Mg Vaginal Prasterone in Menopausal Women With Moderate to Severe Dyspareunia|
|Actual Study Start Date :||August 7, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
6.5 mg vaginal inserts of prasterone will be used daily once the patient meets inclusion and exclusion for 20 weeks.
6.5 vaginal insert prasterone (dehydroepiandrosterone)
Other Name: Intrarosa
- Vulvoscopic changes to the vulva, vestibule, urethral meatus and vaginal region on VGTA scale [ Time Frame: Twenty weeks ]The primary objective of this study is to prospectively document, using vulvoscopy with detailed photography, the visible changes to the vulva, vestibule, urethral meatus and vaginal region in menopausal women with moderate to severe dyspareunia using 6.5 mg daily prasterone for twenty weeks, comparing baseline to 20 weeks. Photographs will be assessed by an independent reviewer using a ten-parameter Likert rating scale, the Vulvoscopic Genitourinary Tissue Appearance (VGTA) scale. This scale assesses for labia majora resorption, labia minora resorption, clitoral atrophy, urethral meatal prolapse, introital stenosis, pallor, erythema, mucosa inflammation, loss of vaginal ruggation, and anterior vaginal wall atrophy. VGTA values for each parameter are 0 (normal), 1(mild), 2 (moderate) or 3 (severe). Each parameter will be calculated separately as well as the total score as primary outcome measure.
- Changes in pain as noted on cotton-tipped swab (Q-tips®) test. [ Time Frame: Twenty weeks ]Secondary objectives include changes in pain as noted on the Pain Scale during the cotton-tipped swab (Q-tips®) test. Pain is assessed by applying pressure with the cotton-tipped swab in 7 specific locations around the vestibule (1:00, 3:00, 5:00, 6:00, 7:00, 9:00 and 11:00) and the patient is asked to assess her pain at each location on a scale of 0-3 with 0 being no pain and 3 being the most severe. The total score is then used to determine outcome.
- Subject diary [ Time Frame: Twenty weeks ]Changes in responses to questions on subject diary from first 4 week period prior to start of medication, to last 4 week period ending at twenty weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568604
|Contact: Wendy Ramirez, BAemail@example.com|
|Contact: JoAnna Williams, CCRCfirstname.lastname@example.org|
|United States, California|
|San Diego Sexual Medicine||Recruiting|
|San Diego, California, United States, 92120|
|Contact: Sue W Goldstein, BA, CCRC 619-265-8865 email@example.com|
|Contact: JoAnna Williams, CCRC 619-265-8865 firstname.lastname@example.org|
|Principal Investigator: Irwin Goldstein, MD|
|Principal Investigator:||Irwin Goldstein, MD||San Diego Sexual Medicine|
|Study Director:||Sue W Goldstein, BA, CCRC||San Diego Sexual Medicine|