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

NCT00367536 | Completed Phase 1

• 1 other identifier: 3115A1-115
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postmenopause

Keywords

Health

Interventions

bazedoxifene/conjugated estrogens combination tablet DRUG

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Interventions

bazedoxifene

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 21, 2006
• First Posted: August 23, 2006
• Study Start: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 1, 2015

Record last verified: 2009-07