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NCT01063855 · ClinicalTrials.gov registry record · Phase 3
Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 495
- Enrollment target
NCT01063855: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT01063855 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 495 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01063855, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 495 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.
Primary Outcome
The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction.
Interventions
- DRUG Placebo
- DRUG Dapoxetine
- DRUG PDE5I (phosphodiesterase-5 inhibitor)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 495 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
What the finished NCT01063855 record still lists
NCT01063855 is an interventional study that assigns participants to a tested intervention. The registered 495 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01063855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01063855 about?
NCT01063855 is a clinical study titled "Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction". The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.
What is the current status of trial NCT01063855?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 495 participants. The study started on 2010-04. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01063855?
The interventions under investigation include: Placebo (DRUG), Dapoxetine (DRUG), PDE5I (phosphodiesterase-5 inhibitor) (DRUG).
Who is sponsoring clinical trial NCT01063855?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01063855's enrollment target sits among peer trials
495 778th of 2000 higher than 1,222 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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