Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

Wyeth

Status and phase: Completed; Phase 1

Conditions: Menopause

Treatments: Drug: bazedoxifene/conjugated estrogens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396799

3115A1-114

Details and patient eligibility

About

The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process

Sex: Female

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs).
• At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater).
• Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days.

Exclusion Criteria

• Women with amenorrhea starting after 54 years of age.
• A history or active presence of clinically important medical diseases.
• Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)