High internal consistency and efficacy of intravaginal DHEA for vaginal atrophy

• Published in: Gynecological endocrinology 2010-07, Vol.26 (7), p.524-532
• Main Authors: Labrie, Fernand, Archer, David, Bouchard, Céline, Fortier, Michel, Cusan, Leonello, Gomez, José-luis, Girard, Ginette, Baron, Mira, Ayotte, Normand, Moreau, Michèle, Dubé, Robert, Côté, Isabelle, Labrie, Claude, Lavoie, Lyne, Berger, Louise, Martel, Céline, Balser, John
• Format: Article
• Language: English
• Subjects: Administration, Intravaginal; Atrophy - drug therapy; Atrophy - pathology; Dehydroepiandrosterone - therapeutic use; DHEA, prasterone; Double-Blind Method; Female; Humans; Intention to Treat Analysis; intracrinology; Postmenopause - drug effects; tissue-specific prehormone replacement therapy (SPRT); Treatment Outcome; Vagina - drug effects; Vagina - pathology; Vaginal atrophy; Vaginal Diseases - drug therapy; Vaginal Diseases - pathology
• ISSN: 0951-3590; 1473-0766
• DOI: 10.3109/09513590903511547

Following the compelling data obtained in a pivotal phase III clinical trial performed in 218 postmenopausal women suffering from vaginal atrophy who received daily intravaginal 0.25, 0.5 or 1.0% DHEA (dehydroepiandrosterone) ovules for 12 weeks, we have performed analysis of the four co-primary objectives at each site of that multicentre U.S. and Canadian trial. Comparison was made of the change in percentage of parabasal and superficial cells, vaginal pH and severity of the most bothersome symptom. The site-by-site (seven sites) analysis has shown that 10-13 women per group are generally sufficient to obtain a significant or highly statistically significant decrease in vaginal pH and percentage of parabasal cells and increased percentage of superficial cells at p values ranging from 0.02 to