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.
painful intercourse |
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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.
Painful Sex Women |
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.