Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: San Diego Sexual Medicine
• Treatments: Dehydroepiandrosterone

Criteria

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 abuse within 12 months prior, or consuming > 14 alcoholic drinks per week;

• has received an investigational drug within 30 days prior to signing consent;

• has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.