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NCT00446199 · ClinicalTrials.gov registry record · Phase 3
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 735
- Enrollment target
NCT00446199: Completed Phase 3 study, sponsored by Bayer.
NCT00446199 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 735 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00446199, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 735 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.
Primary Outcome
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.
Interventions
- DRUG Placebo
- DRUG 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
- DRUG 0.5mg DRSP / 0.5mg E2 (BAY86-4891)
- DRUG Estradiol (E2 0.3mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 735 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-11 |
| Phase | Phase 3 |
What the finished NCT00446199 record still lists
NCT00446199 is an interventional study that assigns participants to a tested intervention. The registered 735 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00446199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00446199 about?
NCT00446199 is a clinical study titled "Low-dose Hormone Therapy for Relief of Vasomotor Symptoms". The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.
What is the current status of trial NCT00446199?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 735 participants. The study started on 2007-03. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00446199?
The interventions under investigation include: Placebo (DRUG), 0.25mg DRSP / 0.5mg E2 (BAY86-4891) (DRUG), 0.5mg DRSP / 0.5mg E2 (BAY86-4891) (DRUG), Estradiol (E2 0.3mg) (DRUG).
Who is sponsoring clinical trial NCT00446199?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00446199's enrollment target sits among peer trials
735 481st of 2000 higher than 1,519 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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