In addition to hot flashes, another troubling symptom of the menopause is painful intercourse (dyspareunia). This condition is often due to vulvovaginal atrophy due to decreased hormone levels. The condition can be treated with hormone replacement therapy (HRT)l however, that comes with an increased risk of breast cancer, particularly among susceptible women. A new study evaluated the use of intravaginal prasterone (dehydroepiandrosterone; DHEA) for the treatment of vulvovaginal atrophy. The findings were published in the September edition of the journal Menopause.
The aim of the study was to confirm the local effects of intravaginal prasterone on moderate to severe dyspareunia associated with menopause. The researchers conducted a randomized, double-blind, placebo-controlled phase III clinical trial, meaning that the women were randomly assigned to receive either prasterone or a placebo and neither the participants nor researchers were aware of whether they received prasterone. The investigators examined the effects of daily intravaginal prasterone (6.5 mg) on four primary objectives: percentage of vaginal parabasal cells, percentage of vaginal superficial cells, vaginal pH, and moderate to severe dyspareunia.
The investigators found that after daily intravaginal prasterone administration for 12 weeks, the percentage of parabasal cells decreased by 45.8% compared to the placebo, the percentage of superficial cells increased by 4.7% over the placebo, and vaginal pH decreased by 0.83 pH units compared to the placebo. All the foregoing were signs of improved vaginal health. In addition, compared to the placebo, the severity of most bothersome dyspareunia decreased by 46% at 12 weeks, and moderate to severe vaginal dryness decreased by 0.43 severity score units (or 42%) compared to the placebo. Gynecologic evaluations revealed a 14.4% to 21.1% improvement in vaginal secretions, epithelial (vaginal lining) integrity, epithelial surface thickness, and color, compared to the placebo. Serum steroid levels remained well within normal postmenopausal concentrations. All endometrial biopsies at 12 weeks have shown atrophy. Both the steroid levels and endometrial biopsies indicated that the there was no systemic effect from intravaginal prasterone.
The authors concluded that daily intravaginal prasterone (0.50%; 6.5 mg) treatment has clinically and statistically significant beneficial effects on the four vulvovaginal atrophy factors evaluated; thus, the medication complied with US Food and Drug Administration (FDA) guidelines. No significant drug-related adverse effect were noted; thus, indicating a high benefit-to-risk ratio for intravaginal prasterone.