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Randomized Controlled Trial
. 2014 Jul;78(3):212-8.
doi: 10.1016/j.maturitas.2014.04.008. Epub 2014 Apr 26.

Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene

Lucy Abraham  1 , JoAnn V Pinkerton  2 , Michael Messig  3 , Kelly A Ryan  4 , Barry S Komm  5 , Sebastian Mirkin  6
Affiliations
Randomized Controlled Trial

Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene

Lucy Abraham et al. Maturitas. 2014 Jul.

Erratum in

  • Maturitas. 2014 Dec;79(4):488

Abstract

Objective: Describe 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.

Design: MSQOL 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 0.625 mg/BZA 20mg and CE 0.45 mg/BZA 20mg were evaluated and compared with established thresholds for clinically important differences (CID).

Results: Significant 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.

Conclusions: CE/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.

Keywords: CE/BZA; Menopause-specific quality of life; Osteoporosis; TSECs; Vasomotor symptoms; Vulvar/vaginal atrophy.

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