Study Evaluating Bazedoxifene/CE in Postmenopausal Women

Wyeth

Status and phase

Completed

Phase 1

Conditions

Postmenopause

Treatments

Device: Bazedoxifene/Conjugated Estrogens

Study type

Interventional

Funder types

Industry

Identifiers

NCT00550433

3115A1-1117

Details and patient eligibility

About

The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.

Sex

Female

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Postmenopausal women aged 35 to 70 years.
Spontaneous or surgical amenorrhea for at least 6 months.
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.

Exclusion criteria

Hypertension or elevated supine blood pressure (>139 mm Hg systolic or >89 mm Hg diastolic).
History of any clinically important drug allergy.
Use of any prescription or investigational drug within 30 days before test article administration.