drugset / Trial / NCT00808132
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
RandomizedParallel-groupQuadruple-blindTreatment
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
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 |