Clinical trial NCT01063855: Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Sexual Dysfunction
Keywords: Erectile Dysfunction
Sexual Dysfunction
Dapoxetine hydrochloride
PRILIGY
Premature ejaculation
Serotonin Uptake Inhibitors
Sildenafil (Viagra)
Vardenafil (Levitra)
Tadalafil (Cialis)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 495
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Premature ejaculation (PE) and erectile dysfunction (ED) are forms of sexual dysfunction in men. An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT), which is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). This is a multicenter, double-blind (neither the physician or the study participant will know the identity of the treatment assigned), randomized (study drug assigned by chance) efficacy and safety study of dapoxetine compared with placebo (a sugar pill) in men with premature ejaculation who are currently being treated for ED with a phosphodiesterase 5 (PDE-5) inhibitor such as sildenafil, vardenafil, or tadalafil. A maximum of 656 men 18 years or older (hereafter referred to as study participants) who have received treatment with a PDE-5 inhibitor for at least 3 months prior to study entry will be enrolled. The study will last approximately 18 weeks and includes a 4-week screening period, a 12-week treatment period, and a follow-up telephone contact approximately 2 weeks after the end of treatment. Both the study participant and his partner will be required to attend the screening visit and to sign an informed consent form documenting that they understand and agree to the requirements for the study. After initial screening procedures are completed, study participants who qualify for the study will enter a 4-week screening period. During the 4 weeks, the study participant and his partner will be provided with a stopwatch to time and record the IELT during all attempts at sexual intercourse. At the next scheduled clinic visit which is Day 1 of the double-blind treatment period, study participants who continue to qualify for the study will be assigned by chance (like flipping a coin) to receive 1 of 2 study treatments (dapoxetine or placebo) for 12 weeks in addition to prescribed treatment with a PDE-5 inhibitor. Study participants will be instructed to take study drug with or without food with at least 1 full glass of water approximately 1 to 3 hours before sexual activity (no more than 1 dose should be taken within a 24-hour period). During the 12-week treatment period, the study participant and his partner will be asked to time and record the IELT during all attempts at sexual intercourse on Treatment Event Logs provided. Study participants will return to the clinic after 4, 8 and 12 weeks of treatment for routine safety assessments (including review of Treatment Event Logs returned) and to be dispensed study drug. Following 12 weeks of treatment (or at the time of early withdrawal from the study) end-of-treatment safety and efficacy evaluations will be performed at the final clinic visit. Approximately 2 weeks later, a follow up telephone call will be made to the study participant to collect information on any adverse events that may have occurred or concomitant therapy received since the time of the last clinic visit. The primary outcome measure in the study is the average IELT, as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12). Safety will be monitored during the study by evaluating adverse events, physical examination findings, results from clinical laboratory tests, and concomitant medication usage. An Independent Data Monitoring Committee (IDMC) will be established to monitor the safety and efficacy of study participants during the study. In addition, an interim (preliminary) analysis will be performed during the study to monitor safety and efficacy after approximately 268 men have completed 12 weeks of treatment (also includes any study participants who did not complete treatment and were withdrawn early from the study). Study participants will receive either dapoxetine or matching placebo tablets at a dose of 30 mg prn (as needed) taken orally (by mouth) with or without food with at least 1 full glass of water approximately 1 to 3 hours before sexual activity (not to be taken more than once every 24 hours). At Weeks 4 or 8, the dose of dapoxetine or matching placebo may be increased to a maximum of 60 mg prn if specific predefined criteria are met or be subsequently decreased from 60 to 30 mg at Weeks 4 or 8.

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

Primary outcomes:
measure: The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation
timeFrame: At the end of treatment (Week 12)
measure: The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation
timeFrame: At Endpoint (After 12 weeks of treatment)
measure: 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
timeFrame: At the end of treatment (Week 12)
measure: The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse
timeFrame: Endpoint (After 12 weeks of treatment)
measure: The Percentage of Patients Reporting At Least a "Better" Response to Treatment
timeFrame: Endpoint (After 12 weeks of treatment)
measure: The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation
timeFrame: Endpoint (After 12 weeks of treatment)
measure: The Percentage of Patients Reporting At Least a "Slightly Better" Response to Treatment
timeFrame: Endpoint (After 12 weeks of treatment)
Other outcomes:
Locations:
city: Decatur
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Englewood
country: United States
state: Colorado
city: Aventura
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Evansville
country: United States
state: Indiana
city: Fort Wayne
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Olive Branch
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Poughkeepsie
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Ettrick
country: United States
state: Virginia
city: Middleton
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma De
country: Argentina
city: Malvern
country: Australia
city: Maroubra
country: Australia
city: Perth
country: Australia
city: St Leonards
country: Australia
city: Brussel
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Liège
country: Belgium
city: Coquitlam
country: Canada
state: British Columbia
city: Guelph
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Garches
country: France
city: Lille
country: France
city: Lyon Cedex 03
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Nimes Cedex 9
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Chunjoo
country: Korea, Republic of
city: Kwangjoo
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kuala Lumpur N/A
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuching
country: Malaysia
city: Petaling Jaya
country: Malaysia
city: Cd. De Mexico
country: Mexico
city: Culiacan
country: Mexico
city: Durango
country: Mexico
city: Monterrey
country: Mexico
city: Katowice
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Szcezecin
country: Poland
city: Wroclaw
country: Poland
city: Moscow
country: Russian Federation
city: St Peterburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Kaohsiung
country: Taiwan
city: Tao-Yuan
country: Taiwan
city: Chipping Norton
country: United Kingdom
city: Leeds Yorkshire
country: United Kingdom
city: Lichfield
country: United Kingdom
city: Reading
country: United Kingdom
city: South Brent
country: United Kingdom
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: McMahon CG, Giuliano F, Dean J, Hellstrom WJ, Bull S, Tesfaye F, Sharma O, Rivas DA, Aquilina JW. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. J Sex Med. 2013 Sep;10(9):2312-25. doi: 10.1111/jsm.12236. Epub 2013 Jul 11.