Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

Summary

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

Timeline

Start

2009-01

Primary completion

2011-02

Completion

2011-02

Outcome

Met primary endpoint

registry Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg vs Placebo; p <0.001; Least Squares (LS) Mean Difference 1.51 (95% CI 0.822 to 2.201); ANCOVA NCT00808132 ↗

registry Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg vs Placebo; p <0.001; LS Mean Difference 1.87 (95% CI 1.209 to 2.533); ANCOVA NCT00808132 ↗

Publications

• Pinkerton JV, Harvey JA, Lindsay R, Pan K, Chines AA, Mirkin S, Archer DF; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. J Clin Endocrinol Metab. 2014 Feb;99(2):E189-98. doi: 10.1210/jc.2013-1707. Epub 2014 Jan 17.
• Pinkerton JV, Harvey JA, Pan K, Thompson JR, Ryan KA, Chines AA, Mirkin S. Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):959-968. doi: 10.1097/AOG.0b013e31828c5974.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bazedoxifene	Other / unclassified	20 mg	Oral
Subject	conjugated estrogens	Other / unclassified	0.45 mg	Oral
Subject	conjugated estrogens	Other / unclassified	0.625 mg	Oral
Comparator	medroxyprogesterone acetate	Other / unclassified	1.5 mg	Oral

Indications