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NCT00196339 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients
A Phase 2 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 315
- Enrollment target
NCT00196339: Completed Phase 2 study, sponsored by Duramed Research.
NCT00196339 is a Phase 2 study that has completed, run by Duramed Research. The registered enrollment target is 315 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (137% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00196339, a Phase 2 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 315 participants
- Enrollment target
Study Summary
This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer patients with hot flashes following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period.
Interventions
- DRUG Placebo
- DRUG Cyproterone acetate 5
- DRUG Cyproterone acetate 15
- DRUG Cyproterone acetate 25
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2005-06 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
What the finished NCT00196339 record still lists
NCT00196339 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (137% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00196339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00196339 about?
NCT00196339 is a clinical study titled "A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients". This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer patients with hot flashes following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must...
What is the current status of trial NCT00196339?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 315 participants. The study started on 2005-06. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00196339?
The interventions under investigation include: Placebo (DRUG), Cyproterone acetate 5 (DRUG), Cyproterone acetate 15 (DRUG), Cyproterone acetate 25 (DRUG).
Who is sponsoring clinical trial NCT00196339?
This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00196339's enrollment target sits among peer trials
315 157th of 2000 higher than 1,842 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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