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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00479778
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 24.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopause	Drug: Bazedoxifene/conjugated estrogens	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic analyses. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Gainesville	Florida	United States	32608

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00479778
• Other Study ID Numbers: 3115A1-1121
• First Posted: May 28, 2007
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: Postmenopause
• Additional relevant MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)

Study Results

No Results Posted as of Dec 28, 2007