Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women W… (NCT03568604) | Clinical Trial Compass
CompletedPhase 4
Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia
United States18 participantsStarted 2018-08-07
Plain-language summary
Open label study at a single research center. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. A physical examination and vulvoscopy with photography of the vulva, vestibule, urethral meatus and vagina will be performed at baseline and every 4 weeks for 20 weeks. Pain diaries will be completed between visits.
Who can participate
Age range21 Years – 80 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* provides written informed consent and HIPAA authorization before any study procedures are conducted;
* has a body mass index (BMI) \< 37 kg/m2
* is menopausal either naturally (at least 12 months amenorrheic) or 6 weeks after a bilateral salpingo-oophorectomy prior to natural menopause; subjects with hysterectomy only must have a serum FSH \> 40 mIU/mL;
* has vulvovaginal atrophy with moderate to severe dyspareunia;
* has at least one score ≥ 2 on cotton-tipped swab test
* agrees to comply with the study procedures and visits.
Exclusion Criteria:
* has a hypersensitivity to DHEA;
* has used prasterone in the past 6 months;
* has documented or suspected breast cancer;
* has undiagnosed genital bleeding:
* has clinically significant findings on physical examination;
* has uncontrolled hypertension;
* has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
* is currently on local or systemic androgen therapy including local or systemic testosterone (washout 14 days for local or topical androgen or non-depot injection, 1 month for depot, 6 months for pellet;
* is currently on local or systemic estrogen therapy or androgen therapy (washout 14 days for vaginal estrogen, 60 days for oral/transdermal therapy);
* is currently using a selective estrogen receptor modulator (SERM) or products that have estrogenic or anti-estrogenic effects within last month;
* has a history of substance a…
What they're measuring
1
Vulvoscopic changes to the vulva, vestibule, urethral meatus and vaginal region on VGTA scale