Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile

doi:10.1016/j.fertnstert.2009.03.113

Fertility and Sterility

Volume 92, Issue 3, September 2009, Pages 1025-1038

https://doi.org/10.1016/j.fertnstert.2009.03.113 Get rights and content

Under an Elsevier user license

open archive

Objective

To evaluate the effects of a tissue-selective estrogen complex (TSEC) composed of bazedoxifene/conjugated estrogens (BZA/CE) on menopausal symptoms, metabolic parameters, and overall safety.

Design

Multicenter, double-blind, placebo- and active-controlled phase 3 trial (Selective estrogens, Menopause, And Response to Therapy [SMART]-1).

Setting

Outpatient clinical.

Patient(s)

Healthy, postmenopausal women (n = 3,397) age 40 to 75 with an intact uterus.

Intervention(s)

Single tablets of BZA (10, 20, or 40 mg), each with CE (0.625 or 0.45 mg); raloxifene 60 mg; or placebo taken daily for 2 years.

Main Outcome Measure(s)

Hot flushes, breast pain, vaginal atrophy, metabolic parameters, and adverse events.

Result(s)

BZA (20 mg)/CE (0.625 or 0.45 mg) significantly reduced the frequency and severity of hot flushes and improved measures of vaginal atrophy compared with placebo. At week 12, the daily number of hot flushes decreased by 51.7% to 85.7% with all BZA/CE doses vs. 17.1% for placebo. BZA/CE improved lipid parameters and homocysteine levels, did not significantly change carbohydrate metabolism, and had only minor effects on some coagulation parameters. The incidences of breast pain and adverse events were similar between BZA/CE and placebo.

Conclusion

The TSEC composed of BZA (20 mg)/CE (0.625 or 0.45 mg) is an effective and safe treatment for menopausal symptoms.

Key Words

Bazedoxifene

breast pain

coagulation

conjugated estrogens

hot flushes

metabolism

vaginal atrophy

Cited by (0)

: Supported by Wyeth Research, Collegeville, Pennsylvania.

: R.A.L. is a clinical trial investigator for Wyeth and is a consultant for Bayer, Schering, Plough-Organon, and Wyeth. J.V.P. is a consultant for Merck, Duramed, Novo Nordisk, and Wyeth, is a board member for Boehringer Ingelheim, National Women's Health Resource, and National American Menopause Society, is a multicenter trial PI for Solvay. M.L.S.G. received research grants from Boehringer-Ingelheim, Proctor & Gamble, and Wyeth and is a consultant for Proctor & Gamble, Wyeth, Eli Lilly, Palatin Technologies, Roche, Sciele, and Upsher-Smith Laboratories. M.H.D. is a speaker for Wyeth. S.R. is an employee of Wyeth Research. J.H.P. is an employee of Wyeth Research. G.C. is an employee of Wyeth Research.

: Clinical trial registration information is available at http://www.ClinicalTrials.gov, NCT00675688.

^*: Clinical Investigators and sites listed in appendix.