Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Healthy Postmenopausal Women

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)

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).