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

Completed · Phase 4

Conditions studied: Dyspareunia

In brief

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.

Key facts

Study ID

NCT03568604

Run by

San Diego Sexual Medicine

People needed

18

Starts

2018-08-07

Expected to finish

2020-01-28

Last updated by the study team

2022-06-09

Who can join

Age: 21 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Diego Sexual Medicine — San Diego, California, United States

Full record on ClinicalTrials.gov

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