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Intravaginal dehydroepiandrosterone (prasterone), a highly efficient treatment of Dyspareunia

Objective To examine the effect of intravaginal dehydroepiandrosterone (DHEA) on pain at sexual activity (dyspareunia) identified as the most bothersome symptom of vaginal atrophy in postmenopausal women at
both screening and day 1. Methods This prospective, randomized, double-blind and placebo-controlled phase III clinical trial studied the effect of prasterone (DHEA) applied locally in the vagina on the severity of dyspareunia in 114 postmenopausal women who had identified dyspareunia as their most bothersome symptom of vaginal atrophy, while meeting the criteria for superficial cells _5% and pH45.0 at both screening and day 1. Results At the standard duration of 12 weeks of treatment, increasing doses of 0.25%, 0.5% and 1.0% DHEA decreased the percentage of parabasal cells by 48.6+6.78%, 42.4+7.36% and 54.9+6.60% (p50.0001 vs. placebo for all) with no change with placebo (p¼0.769). The effects on superficial cells and pH were also highly significant compared to placebo at all DHEA doses. The severity score of pain at sexual activity decreased by 0.5, 1.4, 1.6 and 1.4 units in the placebo and 0.25%, 0.5% and 1.0% DHEA groups, respectively, with the p value of differences from placebo ranging from 0.0017 to 50.0001. Conclusions Intravaginal DHEA, through local estrogen and androgen formation, causes a rapid and highly efficient effect on pain at sexual activity without systemic exposure of the other tissues, thus avoiding the recently reported systemic effects of estrogens.


Reference : CLIMACTERIC 2011;14:282–288

  1. Labrie, D. F. Archer*, C. Bouchard{, M. Fortier{, L. Cusan, J.-L. Gomez, G. Girard{, M. Baron**, N. Ayotte{{,
  2. Moreau{{, R. Dube´***, I. Coˆ te´ , C. Labrie, L. Lavoie, L. Berger, L. Gilbert{{{, C. Martel and J. Balser{{{

EndoCeutics Inc., Quebec City, Canada; *Eastern Virginia Medical School, Obstetrics and Gynecology, Norfolk, USA; {Clinique

de Recherche en Sante´ des Femmes, Quebec City, Canada; {Diex Recherche Inc., Sherbrooke, Canada; **Rapid Medical

Research Inc., Cleveland, USA; {{Clinique Gyne´cologique, Shawinigan, Canada; {{Montreal Clinical Study Center, Montreal,

Canada; ***Centre Hospitalier Affilie´ Universitaire de Que´bec, Quebec City, Canada; {{{McGill University Montreal, Obstetrics

and Gynecology, Montreal, Canada; {{{Veristat Inc., Boston, USA