Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause
Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, et al.
Published in Menopause, Vol. 23 (3), pp. 243-56
Methodology
Phase III randomised, double-blind, placebo-controlled trial of daily intravaginal 0.50% DHEA (prasterone, 6.5 mg) for 12 weeks in postmenopausal women whose most bothersome symptom was moderate to severe pain at sexual activity; 325 on DHEA and 157 on placebo (intent to treat).
Key Findings
Compared with placebo, parabasal cells fell by 27.7%, superficial cells rose by 8.44% and vaginal pH fell by 0.66 units (all P < 0.0001). Pain at sexual activity fell by 0.36 severity units more than placebo (P = 0.0002), and vaginal dryness by 0.27 units more (P = 0.004). Serum steroids stayed within normal postmenopausal values; vaginal discharge was reported by about 6%.
Conclusions
Daily intravaginal 6.5 mg DHEA had significant effects on all four FDA-suggested co-primary endpoints, with a local action and no significant drug-related adverse events.
Limitations
Sponsor-run trial (EndoCeutics) with the developer as lead author; 12 weeks only; the effect over placebo on symptom scores was modest; tests a prescription vaginal product, not oral supplements.
Supplements Studied
pain at sexual activity decreased by 1.42 severity score unit from baseline
Related Health Concerns
Study Details
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