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NCT04600336 · ClinicalTrials.gov registry record · Phase 2
Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
NCT04600336: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT04600336 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04600336, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
Study Summary
This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer . Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy.
Primary Outcome
Using patients' hot flash diaries, daily hot flash scores will be determined by multiplying the frequency of each defined hot flash grade (mild=1, moderate=2, severe=3, very severe=4) by the severity and summing the values over a 24-hour period. Weekly hot flash scores will be computed by averaging these hot flash scores across 7 days. A score of 0 would mean the patient experienced no hot flashes during the week, and every unit increase reflects more or more severe hot flashes experienced. A mi
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Placebo Administration
- DRUG Oxybutynin Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2024-03-11 |
| Phase | Phase 2 |
What the finished NCT04600336 record still lists
NCT04600336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04600336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04600336 about?
NCT04600336 is a clinical study titled "Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer". This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer . Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal...
What is the current status of trial NCT04600336?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2021-10-28. Estimated completion is 2024-03-11.
What interventions are being tested in trial NCT04600336?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Placebo Administration (DRUG), Oxybutynin Chloride (DRUG).
Who is sponsoring clinical trial NCT04600336?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04600336's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,191 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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