Phase 3
N=495
Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction
Erectile Dysfunction · Sexual Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01063855 ↗Enrolled (actual)
495
Serious AEs
1.4%
Results posted
Nov 2012
Primary outcome: Primary: The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 — 1.1; 3.4; 1.1; 5.2 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Dapoxetine (Drug); PDE5I (phosphodiesterase-5 inhibitor) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 |
1.1; 3.4; 1.1; 5.2 | <0.001 sig |
| SECONDARY The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation |
32.3; 45.9 | 0.001 sig |
| SECONDARY The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation |
67.2; 76.4 | 0.013 sig |
| SECONDARY The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress |
30.6; 43.5 | 0.002 sig |
| SECONDARY The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse |
55.0; 66.3 | 0.007 sig |
| SECONDARY The Percentage of Patients Reporting At Least a "Better" Response to Treatment |
35.4; 56.5 | <0.001 sig |
| SECONDARY The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation |
61.6; 67.5 | >0.05 |
| SECONDARY The Percentage of Patients Reporting At Least a "Slightly Better" Response to Treatment |
66.9; 91.3 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01063855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.