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

Postmenopause Clinical Trial

Official title:

An Open-label, Single-dose, Randomized-to-sequence, 4-period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367536
• Other study ID #: 3115A1-115
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2006
• Last updated: April 30, 2015
• Start date: August 2006
• Est. completion date: August 2006

Study information

• Verified date: July 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Postmenopause

Intervention

Drug:
• bazedoxifene/conjugated estrogens combination tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer