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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 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.

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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.

Interventions

  • DRUG Placebo
  • DRUG Dapoxetine
  • DRUG PDE5I (phosphodiesterase-5 inhibitor)

Trial Details

FieldValue
Enrollment Target 495 participants
Start Date 2010-04
Est. Completion 2011-09
Phase Phase 3

What the Registry Record Tells You About NCT01063855

The ClinicalTrials.gov registry entry for NCT01063855 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 495 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01063855 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.