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NCT00550433 Clinical Trial

Study Evaluating Bazedoxifene/CE in Postmenopausal Women

Postmenopause Clinical Trial

Official title:
An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Clinical and Commercial Formulations of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00550433
Other study ID # 3115A1-1117
Secondary ID
Status Completed
Phase Phase 1
First received October 25, 2007
Last updated January 11, 2008
Start date September 2007
Est. completion date November 2007

Study information
Verified date January 2008
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 clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 70 Years
Eligibility Inclusion Criteria:

- Postmenopausal women aged 35 to 70 years.

- Spontaneous or surgical amenorrhea for at least 6 months.

- Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion Criteria:

- Hypertension or elevated supine blood pressure (>139 mm Hg systolic or >89 mm Hg diastolic).

- History of any clinically important drug allergy.

- Use of any prescription or investigational drug within 30 days before test article administration.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Bazedoxifene/Conjugated Estrogens

Locations
Country Name City State
n/a

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

Outcome
Type Measure Description Time frame Safety issue
Primary The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.
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