Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00396799

First received: November 7, 2006

Last updated: March 12, 2007

Last verified: March 2007

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated Bazedoxifene Bazedoxifene acetate

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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 (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators


Principal Investigator:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer

More Information


ClinicalTrials.gov Identifier:	NCT00396799 History of Changes
Other Study ID Numbers:	3115A1-114
Study First Received:	November 7, 2006
Last Updated:	March 12, 2007

Additional relevant MeSH terms:


Estrogens Estrogens, Conjugated (USP) Bazedoxifene Hormones Hormones, Hormone Substitutes, and Hormone Antagonists	Physiological Effects of Drugs Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 19, 2017

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