drugset / Trial / NCT00675688
Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.
Timeline
- Start
- 2002-04
- Primary completion
- 2006-01
- Completion
- 2006-01
Publications
- Archer DF, Freeman EW, Komm BS, Ryan KA, Yu CR, Mirkin S, Pinkerton JV. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials. J Womens Health (Larchmt). 2016 Nov;25(11):1102-1111. doi: 10.1089/jwh.2015.5558. Epub 2016 Sep 27.
- Lobo RA, Pinkerton JV, Gass MLS, Dorin MH, Ronkin S, Pickar JH, Constantine G. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril. 2009 Sep;92(3):1025-1038. doi: 10.1016/j.fertnstert.2009.03.113. Epub 2009 Jul 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bazedoxifene | Other / unclassified | 10 mg | — |
| Subject | Bazedoxifene | Other / unclassified | 20 mg | — |
| Subject | Bazedoxifene | Other / unclassified | 40 mg | — |
| Comparator | Raloxifene | Other / unclassified | 60 mg | — |
| Subject | conjugated estrogens | Other / unclassified | 0.45 mg | — |
| Subject | conjugated estrogens | Other / unclassified | 0.625 mg | — |