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Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published
Date:7/13/2009

formation 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<0.001). Results from the 12-week phase also showed that both low-dose regimens of PREMARIN Vaginal Cream (0.5 g daily and twice weekly) significantly improved the most bothersome symptoms score versus placebo at 12 weeks (P less than or equal to 0.001), including those for dyspareunia (P less than or equal to 0.01).

After 52 weeks of therapy, with the same respective dosing regimens as in the double-blind phase, results were similar to those observed at week 12 and demonstrated the efficacy of PREMARIN Vaginal Cream versus placebo. Endometrial safety was assessed in women who completed the 52-week study period and had evaluable endometrial biopsies. There were no reports of endometrial hyperplasia or endometrial carcinoma in these women in either regimen. In this study, the most common tre
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SOURCE Wyeth Pharmaceuticals
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