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NCT00522873 · ClinicalTrials.gov registry record · Phase 3
Endometrial Safety Study
A Phase 3 study of Postmenopause, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 662
- Enrollment target
- 20
- Study locations
NCT00522873: Completed Phase 3 study of Postmenopause, sponsored by Bayer.
NCT00522873 is a Phase 3 study of Postmenopause that has completed, run by Bayer. The registered enrollment target is 662 participants, above the 120-participant average among 7 other Postmenopause trials with a reported enrollment target (452% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00522873, a Phase 3 study of Postmenopause, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 662 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
Primary Outcome
The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.
Conditions Studied
Interventions
- DRUG 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
- DRUG 0.5mg NETA / 1.0mg E2 (Activella)
Study Locations (20)
California
- - San Diego
- - San Diego
Colorado
- - Denver
- - Greenwood Village
Florida
- - Boynton Beach
- - Clearwater
Louisiana
- - Amite
- - Marrero
Buenos Aires
- - Lanús Oeste
- - San Isidro
Arizona
- - Chandler
Idaho
- - Boise
Nevada
- - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 662 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00522873 record still lists
NCT00522873 is an interventional study that assigns participants to a tested intervention. The registered 662 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 7 other Postmenopause trials with a reported enrollment target (452% higher).
The record links to 1 condition, with Postmenopause appearing as the primary indexed condition, and to 2 interventions - of which 0.25mg DRSP / 0.5mg E2 (BAY86-4891) is the first listed.
NCT00522873 names 20 study sites across 15 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT00522873 about?
NCT00522873 is a clinical study titled "Endometrial Safety Study". The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
What is the current status of trial NCT00522873?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 662 participants. The study started on 2007-08. Estimated completion is 2009-08.
What conditions does trial NCT00522873 study?
This clinical trial studies the following conditions: Postmenopause.
What interventions are being tested in trial NCT00522873?
The interventions under investigation include: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) (DRUG), 0.5mg NETA / 1.0mg E2 (Activella) (DRUG).
Who is sponsoring clinical trial NCT00522873?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00522873 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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