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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01063855




Registration number
NCT01063855
Ethics application status
Date submitted
4/02/2010
Date registered
5/02/2010
Date last updated
24/01/2013

Titles & IDs
Public title
Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction
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
Secondary ID [1] 0 0
R096769PRE3008
Secondary ID [2] 0 0
CR016486
Universal Trial Number (UTN)
Trial acronym
COUPLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction 0 0
Sexual Dysfunction 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Dapoxetine
Treatment: Drugs - PDE5I (phosphodiesterase-5 inhibitor)

Experimental: Dapoxetine + PDE5I - 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 + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.

Placebo comparator: Placebo + PDE5I - 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 + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation
Timepoint [1] 0 0
At the end of treatment (Week 12)
Secondary outcome [2] 0 0
The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation
Timepoint [2] 0 0
At Endpoint (After 12 weeks of treatment)
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
At the end of treatment (Week 12)
Secondary outcome [4] 0 0
The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse
Timepoint [4] 0 0
Endpoint (After 12 weeks of treatment)
Secondary outcome [5] 0 0
The Percentage of Patients Reporting At Least a "Better" Response to Treatment
Timepoint [5] 0 0
Endpoint (After 12 weeks of treatment)
Secondary outcome [6] 0 0
The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation
Timepoint [6] 0 0
Endpoint (After 12 weeks of treatment)
Secondary outcome [7] 0 0
The Percentage of Patients Reporting At Least a "Slightly Better" Response to Treatment
Timepoint [7] 0 0
Endpoint (After 12 weeks of treatment)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
495
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Malvern
Recruitment hospital [2] 0 0
- Maroubra
Recruitment hospital [3] 0 0
- Perth
Recruitment hospital [4] 0 0
- St Leonards
Recruitment postcode(s) [1] 0 0
- Malvern
Recruitment postcode(s) [2] 0 0
- Maroubra
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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Colorado
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Florida
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Mississippi
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Missouri
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New York
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North Carolina
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Ohio
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Oregon
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Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma De
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Liège
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Ontario
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Garches
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Toulouse
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Chunjoo
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Kwangjoo
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Pusan
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Seoul
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Malaysia
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Kuching
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Durango
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Monterrey
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Katowice
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Lodz
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Lublin
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Szcezecin
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Wroclaw
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Russian Federation
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Moscow
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Russian Federation
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St Peterburg
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St Petersburg
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St. Petersburg
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Taiwan
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Kaohsiung
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Taiwan
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Tao-Yuan
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United Kingdom
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Chipping Norton
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United Kingdom
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Leeds Yorkshire
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Lichfield
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Reading
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United Kingdom
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South Brent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01063855
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01063855