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.
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Authors | Lucy Abraham, JoAnn V Pinkerton, Michael Messig, Kelly A Ryan, Barry S Komm, Sebastian Mirkin |
Journal | Maturitas
(Maturitas)
Vol. 78
Issue 3
Pg. 212-8
(Jul 2014)
ISSN: 1873-4111 [Electronic] Ireland |
PMID | 24837362
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 Elsevier Ireland Ltd. All rights reserved. |
Chemical References |
- Estrogens
- Estrogens, Conjugated (USP)
- Indoles
- Selective Estrogen Receptor Modulators
- bazedoxifene
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Topics |
- Double-Blind Method
- Estrogens
(therapeutic use)
- Estrogens, Conjugated (USP)
(therapeutic use)
- Female
- Genital Diseases, Female
(drug therapy)
- Hot Flashes
(prevention & control)
- Humans
- Indoles
(therapeutic use)
- Menopause
- Middle Aged
- Osteoporosis, Postmenopausal
(prevention & control)
- Prospective Studies
- Quality of Life
- Selective Estrogen Receptor Modulators
(therapeutic use)
- Sexual Dysfunction, Physiological
(prevention & control)
- Surveys and Questionnaires
- Vagina
(pathology)
- Vaginal Diseases
(drug therapy)
- Vulva
(pathology)
- Vulvar Diseases
(drug therapy)
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