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

This study has been completed.

First Received: August 21, 2006 Last Updated: July 6, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00367536

Purpose

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.

Condition	Intervention	Phase
Postmenopause	Drug: bazedoxifene/conjugated estrogens combination tablet	Phase I

Study Type:	Interventional
Official Title:	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.

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated Bazedoxifene

U.S. FDA Resources

Further study details as provided by Wyeth:

Estimated Enrollment:	24
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

<p>Inclusion Criteria:</p> <ul> <li>Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)  postmenopausal women aged 35 to 70 years. </li> <li>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 </li> <li>Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg.</li></ul> <p>Exclusion Criteria:</p> <ul> <li>A history or active presence of clinically important medical disease. </li> <li>History or alcoholism or drug abuse within 1 year before study start. </li> <li>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.</li></ul>

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367536

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3115A1-115
Study First Received:	August 21, 2006
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00367536 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Wyeth:

Health

Additional relevant MeSH terms:

Estrogens
Estrogens, Conjugated (USP)
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010