A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Sponsor study identifier
interventional
3,544
0 countries
N/A
Study Start
April 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2006
Actual (reported)Study Completion
January 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2006
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2002
Date type not reportedThis date has not been verified as actual or estimated.
January 2006
Actual (reported)January 2006
Actual (reported)May 7, 2008
Actual (reported)May 12, 2008
Actual (reported)To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.
one year
To evaluate the efficacy of Bazedoxifene/CE combinations in preventing osteoporosis. To evaluate the effects of Bazedoxifene/CE combinations on vaginal atrophy, metabolic parameters, uterine bleeding, vasomotor symptoms and quality of life indices.
one year
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.
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3,544 participants (actual enrollment reported by the registry).
First Submitted
May 7, 2008
First Posted
May 12, 2008
Study Start
April 2002
Date type not reportedThis date has not been verified as actual or estimated.
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2006
Actual (reported)Study Completion
January 2006
Actual (reported)Last Updated
May 12, 2008
Record last verified: 2008-05
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Source: ClinicalTrials.gov.
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