- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00396799
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women
March 12, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Open-Label, Single-Dose, Randomized-to-Sequence, 2-Period, Crossover, Pivotal Bioequivalence Study Between Bazedoxifene Acetate/Conjugated Estrogens (Premarin Current Process) and Bazedoxifene Acetate/Conjugated Estrogens (Premarin New Process) Tablets Administered to Healthy Postmenopausal Women
The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria
- Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs).
- At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater).
- Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days.
Exclusion Criteria
- Women with amenorrhea starting after 54 years of age.
- A history or active presence of clinically important medical diseases.
- Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene.
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety will be evaluated from reported signs and symptoms, scheduled physical examinations, gynecologic examinations, vital sign measurements, 12-lead ECG and clinical laboratory test results.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Study Completion
November 1, 2006
Study Registration Dates
First Submitted
November 7, 2006
First Submitted That Met QC Criteria
November 7, 2006
First Posted (Estimate)
November 8, 2006
Study Record Updates
Last Update Posted (Estimate)
March 13, 2007
Last Update Submitted That Met QC Criteria
March 12, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3115A1-114
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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