Intravaginal dehydroepiandrosterone (Prasterone), a physiological and  highly efficient treatment of vaginal atrophy.
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.
Labrie
Fernand
F
Laval University Hospital Research Center and Laval University, Quebec, Canada. Fernand.Labrie@endoceutics.com
Archer
David
D
Bouchard
Céline
C
Fortier
Michel
M
Cusan
Leonello
L
Gomez
José-Luis
JL
Girard
Ginette
G
Baron
Mira
M
Ayotte
Normand
N
Moreau
Michèle
M
Dubé
Robert
R
Côté
Isabelle
I
Labrie
Claude
C
Lavoie
Lyne
L
Berger
Louise
L
Gilbert
Lucy
L
Martel
Céline
C
Balser
John
J
D000282:Administration, Intravaginal; D000328:Adult; D000704:Analysis of Variance; D001284:Atrophy; D003687:Dehydroepiandrosterone / Q000008:administration & dosage* / Q000172:deficiency* / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects* / Q000502:physiology; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects / Q000473:pathology; D014626:Vaginal Smears
D003687:Dehydroepiandrosterone