Study Evaluating Bazedoxifene/CE in Postmenopausal Women - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00550433

Purpose

The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.

Condition	Intervention	Phase
Postmenopause	Device: Bazedoxifene/Conjugated Estrogens	Phase I

Drug Information available for: Estrogens, conjugated Bazedoxifene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment
Official Title:	An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Clinical and Commercial Formulations of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women

Further study details as provided by Wyeth:

Primary Outcome Measures:

The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.

Study Start Date:	September 2007
Study Completion Date:	November 2007

Eligibility

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

Criteria

Inclusion Criteria:

Postmenopausal women aged 35 to 70 years.
Spontaneous or surgical amenorrhea for at least 6 months.
Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion Criteria:

Hypertension or elevated supine blood pressure (>139 mm Hg systolic or >89 mm Hg diastolic).
History of any clinically important drug allergy.
Use of any prescription or investigational drug within 30 days before test article administration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550433

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3115A1-1117
Study First Received:	October 25, 2007
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00550433
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogens, Conjugated (USP)
Healthy

Additional relevant MeSH terms:

Estrogens
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009