Study Evaluating Premarin and Bazedoxifene Potential Interaction

Postmenopause Clinical Trial

Official title:

An Open-Label, Single/Multiple Dose Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Conjugated Estrogens (CE) On Bazedoxifene In Healthy Postmenopausal Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745173
• Other study ID #: 3115A1-1135
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2008
• Last updated: February 11, 2009
• Start date: September 2008
• Est. completion date: October 2008

Study information

• Verified date: February 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 Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet when administered together with multiple doses of Premarin (conjugated estrogens or CE) to healthy postmenopausal women.

Information will also be obtained regarding the safety and tolerability of this combination in healthy, postmenopausal women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive.

• Blood hormone levels must be consistent with a postmenopausal state (for specified subjects).

• They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able to abstain from smoking during clinic confinements

Exclusion Criteria:

• A subject will be excluded from participation if they :

• Have participated in a clinical drug study within 30 days prior to study medication administration;

• Have a history of drug or alcohol abuse within 1 year or consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine);

• Donate any other plasma or blood during the total study.

Study Design

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

Related Conditions & MeSH terms

• Postmenopause

Intervention

Drug:
• Premarin

Locations

Country	Name	City	State
United States	Dr. David Carter	Austin	Texas

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 (absorption, distribution, breakdown and elimination in the body) parameters		3 months	No
Secondary	To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population.		3 months	Yes