Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Healthy Postmenopausal Women

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00464789

First received: April 23, 2007

Last updated: December 19, 2007

Last verified: December 2007

History of Changes

Purpose

Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed for treatment of menopause. The purpose of this trial is to compare a new manufacturing process for making BZA/CE to the current process by assessing the way it is absorbed into the blood.

Condition	Intervention	Phase
Menopause	Drug: Bazedoxifene/Conjugated Estrogens 20 mg/0.625 mg tablet	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Bazedoxifene/Conjugated Estrogens (Premarin Current Process) And Bazedoxifene/Conjugated Estrogens (Premarin New Process) In Healthy Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Menopause

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:

PK results


Study Start Date:	March 2007
Study Completion Date:	May 2007

Eligibility


Ages Eligible for Study:	35 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Postmenopausal women aged 35 to 70 years
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
Healthy as determined by the investigator on the basis of medical history, physical examination, breast and gynecologic examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

Any clinically important active condition of gynecologic, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
History of any clinically important drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs).

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: NCT00464789

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators


Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer

More Information


ClinicalTrials.gov Identifier:	NCT00464789 History of Changes
Other Study ID Numbers:	3115A1-1120
Study First Received:	April 23, 2007
Last Updated:	December 19, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:


Postmenopausal

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 September 28, 2016

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