Trials / Completed
CompletedNCT01107392
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 315 (actual)
- Sponsor
- Allergan · Industry
- Sex
- Male
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | botulinum toxin Type A | botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. |
| DRUG | Normal saline | Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2012-03-16
- Completion
- 2012-06-08
- First posted
- 2010-04-21
- Last updated
- 2019-05-03
- Results posted
- 2014-04-04
Locations
8 sites across 8 countries: United States, Canada, Czechia, France, Germany, Philippines, Poland, South Korea
Source: ClinicalTrials.gov record NCT01107392. Inclusion in this directory is not an endorsement.