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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 is a Phase 2 study that has completed, run by Duramed Research. The registered enrollment target is 315 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00196339
The ClinicalTrials.gov registry entry for NCT00196339 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00196339 reports 0 study locations.
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.
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