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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00745173
Other study ID # 3115A1-1135
Secondary ID
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


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
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