Elsevier

Obstetrics & Gynecology

Volume 101, Issue 2, February 2003, Pages 346-352
Obstetrics & Gynecology

Original research
Effect of raloxifene on the response to conjugated estrogen vaginal cream or nonhormonal moisturizers in postmenopausal vaginal atrophy

https://doi.org/10.1016/S0029-7844(02)02726-6Get rights and content

Abstract

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 nonhormonal 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).

Section snippets

Materials and methods

Healthy postmenopausal women between the ages of 42 and 80 who had their last menstrual period (natural, not surgical) at least 2 years before study entry and had at least two signs of vaginal atrophy (dryness, pallor, mucosal epithelial thinning, petechiae, loss of rugation of the vaginal lining, or labial atrophy) were included in the study.

Subjects were excluded from enrolling in the study for the following reasons: took estrogen within the previous 3 months or nonestrogen drugs or over the

Results

For the study, 308 women were screened at 16 sites in the United States, and 187 were enrolled. The number of subjects enrolled at an individual site ranged from five to 28. The mean age was 59.4 years (range 42.6 to 80.9), 90.4% were white, the mean weight was 71 kg (range 45–120 kg), the mean height was 162 cm (range 140–183 cm), the mean body mass index was 27.2 kg/m2 (range 18–45), and the mean number of years postmenopausal was 9.5 (range 2–30). There were no significant differences at

Discussion

The objective of this study was to determine whether raloxifene therapy affected the efficacy of low-dose conjugated estrogen cream or nonhormonal moisturizer in treating the signs and symptoms of vaginal atrophy in postmenopausal women. All of the women enrolled in this study presented with objective signs of vaginal atrophy, rated as mild to moderate in severity. As has been shown previously, both low-dose conjugated estrogen cream and nonhormonal moisturizer improve signs and symptoms of

References (9)

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The authors acknowledge Rodney Basson, PhD, for the statistical analysis, and Evista Study Investigator physicians Louis Cohen, Maurice Cohen, Robert Friedman, Phillip Goldstein, Bruce Kessel, William Koltun, Cynthia Krause, Robin Kroll, Thomas Melchione, Damon Raphael, Richard Reindollar, Marguerite Shepherd, Patricia Sulak, and Brian Walsh.

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