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NCT00479778 Clinical Trial

Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms

Postmenopause Clinical Trial

Official title:
An Open Label, Randomized, Multicenter Study To Compare Bazedoxifene Steady-State Exposures Obtained With 2 Bazedoxifene Acetate/Conjugated Estrogen Formulations In Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00479778
Other study ID # 3115A1-1121
Secondary ID
Status Completed
Phase Phase 1
First received May 25, 2007
Last updated December 19, 2007
Start date April 2007
Est. completion date July 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens. It is an open label study with no placebo control or comparator drugs. Subjects will take one dose of the investigation formulation daily for 14 days.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 65 Years
Eligibility - Postmenopausal women, aged 40 to 65 years.

- Use of oral estrogen-, progestin-, or androgen-, or SERM-containing drug products within 8 weeks before screening.

- A history or active presence of clinically relevant important medical disease.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bazedoxifene/conjugated estrogens

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic analyses.
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