Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Healthy Postmenopausal Women

Wyeth

Status and phase

Completed

Phase 1

Conditions

Menopause

Treatments

Drug: Bazedoxifene/Conjugated Estrogens 20 mg/0.625 mg tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT00464789

3115A1-1120

Details and patient eligibility

About

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.

Sex

Female

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

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).