Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

NCT ID: NCT00396799

Last Updated: 2007-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2006-11-30

Brief Summary

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

Conditions

Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bazedoxifene/conjugated estrogens

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Medical Monitor

Role: PRINCIPAL_INVESTIGATOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

3115A1-114

Identifier Type: -

Identifier Source: org_study_id