Abstract
ObjectiveDescribe the effects of conjugated estrogens/bazedoxifene (CE/BZA), a new treatment for vasomotor symptoms (VMS) and osteoporosis prevention, on menopause-specific quality of life (MSQOL) across different patient population types in phase 3 clinical trials. DesignMSQOL was prospectively evaluated in 4 randomized, double-blind, placebo-controlled studies. The populations studied included healthy, non-hysterectomized postmenopausal women with symptomatic VMS or vulvar–vaginal atrophy (VVA) and general postmenopausal women (eligible regardless of symptoms). Menopause-specific Quality of Life (MENQOL) questionnaire total and domain scores for CE 0.625mg/BZA 20mg and CE 0.45mg/BZA 20mg were evaluated and compared with established thresholds for clinically important differences (CID). ResultsSignificant improvements compared with placebo were found with both CE/BZA doses in MENQOL vasomotor domain (−0.61 to −2.23 over 3–24 months) and total scores (−0.24 to −0.94) in the general and symptomatic VMS/VVA populations. Significant improvement compared with placebo in sexual domain (−0.11 to −0.72) was observed with the higher dosage for all populations, and with the lower dosage in the VVA (−0.71 at month 3) and general populations (−0.4 at months 12 and 24). Improvements in vasomotor domain exceeded the CID with both doses in symptomatic VMS populations and with the higher dosage in women with symptomatic VVA; for total MENQOL, the CID was exceeded with the higher dose in symptomatic VMS populations. ConclusionsCE/BZA significantly improved overall and vasomotor-related MSQOL across populations of postmenopausal women with varying baseline symptom statuses. Women with greater menopausal symptoms at baseline were more likely to experience clinically meaningful changes.
Published Version
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