Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

Completed · Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction, Sexual Dysfunction

In brief

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.

Key facts

Study ID

NCT01063855

Run by

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

People needed

495

Starts

2010-04-01

Expected to finish

2011-09-01

Last updated by the study team

2013-01-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of erectile dysfunction (ED), International Index of Erectile Function (IIEF) score >=21 at screening and baseline, and receiving treatment with a stable regimen of a phosphodiesterase 5 (PDE 5) inhibitor (ie, sildenafil, vardenafil, or tadalafil) for the treatment of ED for at least 3 months before screening
• Study participant in a stable, monogamous sexual relationship with the same woman for at least 6 months before screening and plan to maintain this relationship for the duration of the study
• Study participant medically stable (ie, in good general health) on the basis of physical examination, medical history, vital signs, 12 lead ECG, and clinical laboratory tests performed at screening

You may not qualify if…

• History suggestive of syncope (a condition characterized by a loss of consciousness)
• History of medical events such as surgical interventions or neurologic conditions (eg, multiple sclerosis), trauma, or infections that are associated with the development of symptoms of premature ejaculation (PE) and considered a potential cause of PE
• Current major psychiatric disorder such as mood disorder, anxiety disorder, schizophrenia, mania, suicidal ideation, other psychotic disorder, or alcoholism
• Known allergy, hypersensitivity, or intolerance to selective serotonin reuptake inhibitors (SSRIs) or selective noradrenaline reuptake inhibitors (SNRIs)
• Taken another investigational drug (or vaccine) within 30 days or used an investigational medical device within 6 months before screening, or enrolled in another investigational study

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Englewood, Colorado, United States
• Study site — Aventura, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Evansville, Indiana, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Olive Branch, Mississippi, United States
• Study site — Kansas City, Missouri, United States
• Study site — Poughkeepsie, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Salem, Oregon, United States
• Study site — Ettrick, Virginia, United States
• Study site — Middleton, Wisconsin, United States
• Study site — Buenos Aires, Argentina
• Study site — Ciudad Autonoma de, Argentina
• Study site — Malvern, Australia
• Study site — Maroubra, Australia
• Study site — Perth, Australia
• Study site — St Leonards, Australia
• Study site — Decatur, Alabama, United States

Full record on ClinicalTrials.gov

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