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Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

NCT01063855 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2013-01-24

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

Tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.

DRUG

Dapoxetine

30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.

DRUG

PDE5I (phosphodiesterase-5 inhibitor)

Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED) for at least 3 months before screening and up to 12 weeks during treatment in the study.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • France
  • Malaysia
  • Mexico
  • Poland
  • Russia
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063855 on ClinicalTrials.gov