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NCT00808132 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,886
- Enrollment target
NCT00808132: Completed Phase 3 study, sponsored by Pfizer.
NCT00808132 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,886 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00808132, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,886 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.
Primary Outcome
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed bu
Interventions
- DRUG Placebo
- DRUG bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
- DRUG bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
- DRUG bazedoxifene 20 mg
- DRUG conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,886 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
What the finished NCT00808132 record still lists
NCT00808132 is an interventional study that assigns participants to a tested intervention. Its 1,886 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (144% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00808132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00808132 about?
NCT00808132 is a clinical study titled "Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis". The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months...
What is the current status of trial NCT00808132?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,886 participants. The study started on 2009-01. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00808132?
The interventions under investigation include: Placebo (DRUG), bazedoxifene 20 mg/ conjugated estrogens 0.45 mg (DRUG), bazedoxifene 20 mg/ conjugated estrogens 0.625 mg (DRUG), bazedoxifene 20 mg (DRUG), conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg (DRUG).
Who is sponsoring clinical trial NCT00808132?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00808132's enrollment target sits among peer trials
1,886 113th of 2000 higher than 1,888 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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