Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00396799

Purpose

The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process

Condition	Intervention	Phase
Menopause	Drug: bazedoxifene/conjugated estrogens	Phase I

MedlinePlus related topics: Menopause

Drug Information available for: Estrogens, conjugated Bazedoxifene Bazedoxifene Acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
Official Title:	An Open-Label, Single-Dose, Randomized-to-Sequence, 2-Period, Crossover, Pivotal Bioequivalence Study Between Bazedoxifene Acetate/Conjugated Estrogens (Premarin Current Process) and Bazedoxifene Acetate/Conjugated Estrogens (Premarin New Process) Tablets Administered to Healthy Postmenopausal Women

Further study details as provided by Wyeth:

Primary Outcome Measures:

Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene.

Secondary Outcome Measures:

Safety will be evaluated from reported signs and symptoms, scheduled physical examinations, gynecologic examinations, vital sign measurements, 12-lead ECG and clinical laboratory test results.

Study Start Date:	November 2006
Estimated Study Completion Date:	November 2006

Eligibility

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

Criteria

Inclusion Criteria

Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs).
At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater).
Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days.

Exclusion Criteria

Women with amenorrhea starting after 54 years of age.
A history or active presence of clinically important medical diseases.
Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396799

Sponsors and Collaborators

Wyeth

Investigators

Principal Investigator:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3115A1-114
Study First Received:	November 7, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00396799
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogens, Conjugated (USP)
Healthy
Menopause

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 14, 2009