Objective: The objective of this study was to provide evidence that the transformation of DHEA into both
androgens and/or estrogens locally in cells of the three layers of the vagina (epithelium, lamina propria, and
muscularis) would have effects of greater impact, including effects on sexual function, than only effects on
superficial epithelial cells as achieved with estrogens.
Methods: This prospective, randomized, double-blind, and placebo-controlled phase III clinical trial has evaluated
the effect of daily local intravaginal application of Prasterone (dehydroepiandrosterone; DHEA) for 12 weeks on the
domains of sexual dysfunction, namely, desire/interest, arousal, orgasm, and pain at sexual activity, in 216 postmenopausal
women with moderate to severe symptoms of vaginal atrophy.
Results: A time- and dose-dependent improvement of the four domains of sexual function was observed. At
the 12-week time interval, the 1.0% DHEA dose led, compared with placebo, to 49% (P = 0.0061) and 23%
(P = 0.0257) improvements of the desire domains in the Menopause Specific Quality of Life and Abbreviated Sex
Function questionnaires, respectively. Compared with placebo, the Abbreviated Sex Function arousal/sensation
domain was improved by 68% (P = 0.006), the arousal/lubrication domain by 39% (P = 0.0014), orgasm by 75%
(P = 0.047), and dryness during intercourse by 57% (P = 0.0001).
Conclusions: By a local action in the vagina, DHEA applied daily at doses at which serum steroids remain well
within normal postmenopausal values exerts relatively potent beneficial effects on all four aspects of sexual dysfunction.
Such data indicate that combined androgenic/estrogenic stimulation in the three layers of the vagina exerts
important beneficial effects on sexual function in women without systemic action on the brain and other extravaginal tissues.
Menopause: The Journal of The North American Menopause Society
Vol. 16, No. 5, pp. 923/931
* 2009 by The North American Menopause Society