WYE Wyeth

COLLEGEVILLE, Pa., July 13 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced the publication of data that supported daily and twice-weekly use of PREMARIN (conjugated estrogens) Vaginal Cream 0.5 g to relieve some of the bothersome symptoms of moderate-to-severe vulvar and vaginal atrophy, including painful intercourse (dyspareunia). This study evaluated the efficacy of two low-dose regimens of conjugated estrogens (CE) cream (0.5 g daily and twice weekly) using a double-blind, placebo-controlled study design for 12 weeks followed by a 40-week open-label phase. Endometrial safety for both dosing regimens was also assessed in women who completed 52 weeks of therapy. These study results are published in the July/August issue of Menopause: The Journal of the North American Menopause Society. In this study, dyspareunia was the most bothersome symptom at baseline (57%) followed by vaginal dryness, itching and burning.Unlike hot flashes or night sweats, signs and symptoms of vaginal atrophy have been shown to increase over time in postmenopausal women. "Based on market research data, we understand that many postmenopausal women are not discussing their symptoms with their health care professionals," says Gloria Bachmann, M.D., lead study author and director of the Women's Health Institute at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, N.J., and chief of the OB/GYN service at the teaching hospital. "We are encouraged by this 52-week data that showed twice-weekly use of PREMARIN Vaginal Cream was sufficient to provide relief from painful intercourse due to menopause. The study also supported daily use of PREMARIN Vaginal Cream 0.5 g to treat postmenopausal vaginal dryness. This information should aid postmenopausal women and their health care professionals in discussing whether and how they may treat vaginal atrophy." Study Design and Results: In this multicenter clinical study, 423 postmenopausal women (ages 45-80 years) with moderate-to-severe vaginal atrophy were randomized to receive PREMARIN Vaginal Cream 0.5 g (equivalent to a low-dose of CE cream 0.3 mg) or placebo once daily (21 days on/7 days off) or twice weekly for 12 weeks. Treatment regimens were consistent within the 12-week and 40-week periods. The primary endpoints of the study were changes in vaginal maturation index (VMI; percentage of superficial cells), vaginal pH and severity of participant-reported most bothersome symptom (vaginal dryness, itching, burning or dyspareunia) at week 12.The study also evaluated safety related to systemic effects of CE cream on endometrial tissue during one year of therapy. At week 12, improvements in VMI and vaginal pH with daily and twice-weekly use of PREMARIN Vaginal Cream 0.5 g were significantly greater relative to placebo (P