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Effect of Raloxifene on the Response to Conjugated Estrogen Vaginal Cream or Nonhormonal Moisturizers in Postmenopausal Vaginal Atrophy

From the University of South Florida, Tampa, Florida; Washington University, St. Louis, Missouri; and Eli Lilly and Company, Indianapolis, Indiana.

Address reprint requests to: Anna Parsons, MD, University of South Florida, College of Medicine, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Suite 529, Harbourside Medical Tower, 4 Columbia Drive, Tampa, FL 33606; E-mail: aparsons{at}hsc.usf.edu.

OBJECTIVE: To study the effect of raloxifene on the response to conjugated estrogen cream or nonhormonal moisturizer in postmenopausal women with preexisting signs of vaginal atrophy.

METHODS: Postmenopausal women with preexisting and untreated vaginal atrophy were enrolled in this parallel, placebo-controlled, randomized study. A total of 187 women were randomized to four treatment groups: daily oral raloxifene (60 mg per day) or a placebo in a double-blind manner plus one application of conjugated estrogen cream (0.5 g) or one applicator full of nonhormonal moisturizer, open label. The conjugated estrogen cream or non-hormonal moisturizer was applied daily for the first 2 weeks, and then twice weekly thereafter for 3 months. Efficacy of treatment regimens on signs and symptoms of vaginal atrophy was evaluated by monitoring objective and subjective parameters.

RESULTS: Signs and symptoms of vaginal atrophy improved in all four treatment groups. Raloxifene did not diminish the magnitude of improvement when administered with either vaginal preparation. Conjugated estrogen cream produced a statistically greater improvement in signs (P < .05) but not in individual symptoms or overall satisfaction relative to nonhormonal moisturizer.

CONCLUSION: Postmenopausal women with evidence of preexisting vaginal atrophy may use either low-dose conjugated estrogen cream or nonhormonal moisturizer to treat the atrophy concurrently with raloxifene (60 mg per day).

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