Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01063855
• Date of registration: 04/02/2010
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction COUPLE
• Scientific title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase-5 Inhibitor
• Date of first enrolment: April 2010
• Target sample size: 495
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01063855
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Canada, France, Korea, Republic of, Malaysia, Mexico, Poland, Russian Federation, Taiwan, United Kingdom, United States

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Erectile Dysfunction

Sexual Dysfunction

Intervention(s)

Drug: Dapoxetine

Drug: Placebo

Drug: PDE5I (phosphodiesterase-5 inhibitor)

Primary Outcome(s)

The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation [Time Frame: At Endpoint (After 12 weeks of treatment)]

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 [Time Frame: At the end of treatment (Week 12)]

The Percentage of Patients Reporting At Least a "Better" Response to Treatment [Time Frame: Endpoint (After 12 weeks of treatment)]

The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation [Time Frame: At the end of treatment (Week 12)]

The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation [Time Frame: Endpoint (After 12 weeks of treatment)]

The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse [Time Frame: Endpoint (After 12 weeks of treatment)]

The Percentage of Patients Reporting At Least a "Slightly Better" Response to Treatment [Time Frame: Endpoint (After 12 weeks of treatment)]

Secondary ID(s)

R096769PRE3008

2009-013616-12

CR016486

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/11/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01063855