Effects of bazedoxifene/conjugated estrogens on quality of life in postmenopausal women with symptoms of vulvar/vaginal atrophy.
Author(s): Bachmann G, Bobula J, Mirkin S
Affiliation(s): Department of Obstetrics, Gynecology and Reproductive Sciences, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
Publication date & source: 2010-04, Climacteric., 13(2):132-40.
Publication type: Clinical Trial, Phase III; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
OBJECTIVE: To evaluate the effects of the tissue selective estrogen complex (TSEC) pairing bazedoxifene (BZA) with conjugated estrogens (CE) on sexual function and quality of life in postmenopausal women. METHODS: In this 12-week, double-blind, placebo-controlled study, postmenopausal, non-hysterectomized women (n = 652) with symptoms of moderate to severe vulvar/vaginal atrophy were randomized to once-daily treatment with BZA 20 mg/CE 0.45 or 0.625 mg, BZA 20 mg, or placebo. The Arizona Sexual Experiences (ASEX) Scale, Menopause-Specific Quality of Life (MENQOL) questionnaire, and Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) were secondary measures used to assess the effects of BZA/CE on sexual function, menopausal symptoms, and satisfaction with treatment, respectively. RESULTS: At week 12, both BZA/CE doses were associated with significant improvement in ease of lubrication score from baseline compared with placebo (p < 0.05) on the ASEX scale, although there was no difference in the change in total score. The MENQOL questionnaire results at week 12 showed significant improvements in vasomotor function, sexual function and total scores with both BZA/CE doses vs. placebo or BZA 20 mg (p < 0.001). The MS-TSQ results showed that BZA/CE-treated subjects reported significantly greater overall satisfaction with treatment, as well as satisfaction with control of hot flushes during the day and night, effect on quality of sleep, and effect on mood or emotions, compared with subjects treated with placebo or BZA 20 mg (all p < 0.05). CONCLUSION: Treatment with BZA/CE for 12 weeks was shown to significantly improve sexual function and quality-of-life measures in symptomatic postmenopausal women.