Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00367536
First received: August 21, 2006
Last updated: July 6, 2009
Last verified: July 2009

August 21, 2006
July 6, 2009
August 2006
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Complete list of historical versions of study NCT00367536 on ClinicalTrials.gov Archive Site
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Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution
An Open-Label, Single-Dose, Randomized-to-Sequence, 4-Period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women.

This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).

About 24 subjects will take part in this study. Each subject's participation in this study will last for about 10 weeks. During this study, each subject will receive 3 different types of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA oral solution. In addition, information will also be learned about the safety and tolerability of these dosage forms given to healthy postmenopausal women.

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Interventional
Phase 1
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Postmenopause
Drug: bazedoxifene/conjugated estrogens combination tablet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2006
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Inclusion Criteria: Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)  postmenopausal women aged 35 to 70 years. At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL.  Women 55 years of older must have at least 12 months of amenorrhea Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg. Exclusion Criteria: A history or active presence of clinically important medical disease. History or alcoholism or drug abuse within 1 year before study start. Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of administration within 6 months before study day 1 must be approved by Wyeth Research. 

Female
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00367536
3115A1-115
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Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP