"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. 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," scientists writing in the Menopause - the Journal of the North American Menopause Society report (see also Menopause).
"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. 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," wrote F. Labrie and colleagues.
The researchers concluded: "This approach avoids the fear of systemic effects common to all presently available estrogen formulations and adds a novel physiological androgenic component to therapy."
Labrie and colleagues published their study in Menopause - the Journal of the North American Menopause Society (Intravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy. Menopause - the Journal of the North American Menopause Society, 2009;16(5):907-922).
Additional information can be obtained by contacting F. Labrie, Endoceutics Inc., 2989 Promenade, Quebec City, PQ G1W 2J5, Canada.
The publisher of the Menopause - the Journal of the North American Menopause Society can be contacted at: Lippincott Williams & Wilkins, 530 Walnut St., Philadelphia, PA 19106-3621, USA.
Keywords: Canada, Atrophy, Clinical Trial Research, DHEA, Endocrinology, Estrogen, Gynecology, Hormones, Menopause, Neurology, Physiology, Therapy, Treatment.
This article was prepared by Aging & Elder Health Week editors from staff and other reports. Copyright 2009, Aging & Elder Health Week via NewsRx.com.
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