Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution

Wyeth

Status and phase: Completed; Phase 1

Conditions: Postmenopause

Treatments: Drug: bazedoxifene/conjugated estrogens combination tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367536

3115A1-115

Details and patient eligibility

About

This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).

About 24 subjects will take part in this study. Each subject's participation in this study will last for about 10 weeks. During this study, each subject will receive 3 different types of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA oral solution. In addition, information will also be learned about the safety and tolerability of these dosage forms given to healthy postmenopausal women.

Sex: Female

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)
• Postmenopausal women aged 35 to 70 years
• At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL
• Women 55 years of older must have at least 12 months of amenorrhea
• Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg

Exclusion criteria

• A history or active presence of clinically important medical disease.
• History or alcoholism or drug abuse within 1 year before study start.
• Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of administration within 6 months before study day 1 must be approved by Wyeth Research