Skip Navigation LinksHome > September/October 2009 - Volume 16 - Issue 5 > Intravaginal dehydroepiandrosterone (Prasterone), a physiolo...
Menopause:
doi: 10.1097/gme.0b013e31819e8e2d
Articles

Intravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy

Labrie, Fernand MD, PhD1,2; Archer, David MD3; Bouchard, Céline MD4; Fortier, Michel MD4; Cusan, Leonello MD, PhD1; Gomez, José-Luis MD, PhD1; Girard, Ginette MD5; Baron, Mira MD6; Ayotte, Normand MD7; Moreau, Michèle MD8; Dubé, Robert MD9; Côté, Isabelle BSc CCRP2; Labrie, Claude MD, PhD1,2; Lavoie, Lyne MSc2; Berger, Louise PhD2; Gilbert, Lucy MD10; Martel, Céline PhD2; Balser, John PhD11

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Abstract

Objective: Because the secretion of dehydroepiandrosterone (DHEA), the exclusive source of sex steroids in postmenopausal women, is already decreased by 60% and continues to decline at the time of menopause, the objective of this study was to examine the effect of intravaginal DHEA on the symptoms and signs of vaginal atrophy.

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 signs and symptoms of vaginal atrophy in 216 postmenopausal women.

Results: All three doses (0.25%, 0.5%, and 1.0%) of DHEA ovules applied daily intravaginally induced a highly significant beneficial change in the percentage of vaginal parabasal and superficial cells and pH as well as in the most bothersome symptom at 2 weeks. At the standard 12-week time interval, 0.5% DHEA caused a 45.9 ± 5.31 (P < 0.0001 vs placebo) decrease in the percentage of parabasal cells, a 6.8 ± 1.29% (P < 0.0001) increase in superficial cells, a 1.3 ± 0.13 unit (P < 0.0001) decrease in vaginal pH, and a 1.5 ± 0.14 score unit (P < 0.0001) decrease in the severity of the most bothersome symptom. Similar changes were seen on vaginal secretions, color, epithelial surface thickness, and epithelial integrity. Comparable effects were observed at the 0.25% and 1.0% DHEA doses.

Conclusions: Local Prasterone, through local androgen and estrogen formation, causes a rapid and efficient reversal of all the symptoms and signs of vaginal atrophy with no or minimal changes in serum steroids, which remain well within the normal postmenopausal range. This approach avoids the fear of systemic effects common to all presently available estrogen formulations and adds a novel physiological androgenic component to therapy.

©2009The North American Menopause Society

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