Original researchEffect of raloxifene on the response to conjugated estrogen vaginal cream or nonhormonal moisturizers in postmenopausal vaginal atrophy☆
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)
- et al.
Adverse events reported by postmenopausal women in controlled trials with raloxifene
Obstet Gynecol
(1999) Comparative studyReplens versus local estrogen in menopausal women
Fertil Steril
(1994)- et al.
Replens versus dienoestrol cream in the symptomatic treatment of vaginal atrophy in postmenopausal women
Maturitas
(1996) - et al.
Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women
N Engl J Med
(1997)
Cited by (54)
Vaginal Dryness
2018, Integrative Medicine: Fourth EditionRole of Estrogens and Estrogen-Like Compounds in Female Sexual Function and Dysfunction
2016, Journal of Sexual MedicineCitation Excerpt :The effects of local vaginal estrogen with and without concurrent raloxifene were examined in two RCTs. In women treated with conjugated estrogen cream76 or an E2 vaginal ring,77 there were similar improvements in signs and symptoms of vaginal atrophy, suggesting raloxifene did not block local estrogen effects. Ospemifene, a new-generation SERM developed specifically for VVA, was approved by the U.S. Food and Drug Administration in 2013 and represents the first non-estrogenic prescription therapy for VVA.
Use of SERMs for treatment in postmenopausal women
2014, Journal of Steroid Biochemistry and Molecular BiologyCitation Excerpt :Similar to tamoxifen, raloxifene has not been shown to be beneficial in premenopausal women [64,65]. Raloxifene has not been shown to increase the risk of uterine cancers [17,24,83], even when combined with vaginal estrogen [84,85]. However, when raloxifene was combined with oral estradiol, an increase in uterine hyperplasia including atypical hyperplasia was found [54].
Vaginal Dryness
2012, Integrative Medicine, Third EditionThe Effect of Citrus Aurantium Vaginal Cream on Vaginal Atrophy in Postmenopausal Women: A Quasi-experimental Study
2024, International Journal of Community Based Nursing and MidwiferyNonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause: A Systematic Review
2023, Obstetrics and Gynecology
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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.