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NCT01917006 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
A Phase 2 study, sponsored by Allergan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT01917006: Clinical Trial Phase 2 study, sponsored by Allergan.
NCT01917006 is a Phase 2 study that was terminated before completion, run by Allergan. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01917006, a Phase 2 study, was terminated before completion, sponsored by Allergan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.
Primary Outcome
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric
Interventions
- DRUG Normal Saline
- DRUG OnabotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2013-08-07 |
| Est. Completion | 2017-08-15 |
| Phase | Phase 2 |
Why NCT01917006 stopped before completion
NCT01917006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT01917006 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01917006 about?
NCT01917006 is a clinical study titled "A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation". This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.
What is the current status of trial NCT01917006?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2013-08-07. Estimated completion is 2017-08-15.
What interventions are being tested in trial NCT01917006?
The interventions under investigation include: Normal Saline (DRUG), OnabotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT01917006?
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 NCT01917006's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 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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