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NCT01107392 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 315
- Enrollment target
NCT01107392: Completed Phase 2 study, sponsored by Allergan.
NCT01107392 is a Phase 2 study that has completed, run by Allergan. 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
NCT01107392, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 315 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.
Primary Outcome
IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.
Interventions
- DRUG Normal saline
- DRUG botulinum toxin Type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2010-08-01 |
| Est. Completion | 2012-06-08 |
| Phase | Phase 2 |
What the finished NCT01107392 record still lists
NCT01107392 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 2 interventions - of which Normal saline is the first listed.
NCT01107392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01107392 about?
NCT01107392 is a clinical study titled "Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia". This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.
What is the current status of trial NCT01107392?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 315 participants. The study started on 2010-08-01. Estimated completion is 2012-06-08.
What interventions are being tested in trial NCT01107392?
The interventions under investigation include: Normal saline (DRUG), botulinum toxin Type A (DRUG).
Who is sponsoring clinical trial NCT01107392?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01107392'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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