Prasterone: A Review in Vulvovaginal Atrophy

Area of Science:

• Gynecology
• Endocrinology
• Women's Health

Background:

• Vulvovaginal atrophy (VVA) is a common, progressive condition in postmenopausal women.
• Decreased estrogen and dehydroepiandrosterone (DHEA) levels contribute to VVA development.
• Intravaginal prasterone is a synthetic DHEA treatment for VVA symptoms.

Purpose of the Study:

• To evaluate the efficacy and safety of intravaginal prasterone for treating VVA in postmenopausal women.
• To assess the impact of prasterone on VVA signs and symptoms, including dyspareunia.

Main Methods:

• Phase III clinical trials (ERC-231, -238) assessed VVA signs and symptoms compared to placebo.
• A 52-week safety trial (ERC-230) monitored adverse events and hormonal changes.
• Vaginal cytology, pH, and dyspareunia severity were key efficacy measures.

Main Results:

• Intravaginal prasterone significantly improved VVA signs and symptoms versus placebo.
• Beneficial effects were sustained over 52 weeks of treatment.
• Prasterone was generally well-tolerated, with application site discharge as the most common adverse event.

Conclusions:

• Intravaginal prasterone offers an effective treatment option for moderate to severe VVA in postmenopausal women.
• Hormonal metabolite levels remained within normal postmenopausal ranges during treatment.
• Prasterone demonstrates a favorable safety and efficacy profile for VVA management.