Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction (COUPLE)

January 16, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
495

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Ciudad Autonoma De, Argentina
  • Australia
      • Malvern, Australia
      • Maroubra, Australia
      • Perth, Australia
      • St Leonards, Australia
  • Belgium
      • Brussel, Belgium
      • Bruxelles, Belgium
      • Edegem, Belgium
      • Liège, Belgium
  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada
    • Ontario
      • Guelph, Ontario, Canada
      • Newmarket, Ontario, Canada
      • Oakville, Ontario, Canada
      • Sarnia, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Pointe-Claire, Quebec, Canada
  • France
      • Garches, France
      • Lille, France
      • Lyon, France
      • Lyon Cedex 03, France
      • Marseille, France
      • Nimes Cedex 9, France
      • Paris, France
      • Toulouse, France
  • Korea, Republic of
      • Chunjoo, Korea, Republic of
      • Kwangjoo, Korea, Republic of
      • Pusan, Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Kuala Lumpur, Malaysia
      • Kuala Lumpur N/A, Malaysia
      • Kuching, Malaysia
      • Petaling Jaya, Malaysia
  • Mexico
      • Cd. De Mexico, Mexico
      • Culiacan, Mexico
      • Durango, Mexico
      • Monterrey, Mexico
  • Poland
      • Katowice, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Szcezecin, Poland
      • Wroclaw, Poland
  • Russian Federation
      • Moscow, Russian Federation
      • St Peterburg, Russian Federation
      • St Petersburg, Russian Federation
      • St. Petersburg, Russian Federation
  • Taiwan
      • Kaohsiung, Taiwan
      • Tao-Yuan, Taiwan
  • United Kingdom
      • Chipping Norton, United Kingdom
      • Leeds Yorkshire, United Kingdom
      • Lichfield, United Kingdom
      • Reading, United Kingdom
      • South Brent, United Kingdom
  • United States
    • Alabama
      • Decatur, Alabama, United States
      • Huntsville, Alabama, United States
    • Colorado
      • Englewood, Colorado, United States
    • Florida
      • Aventura, Florida, United States
      • Clearwater, Florida, United States
      • Gainesville, Florida, United States
      • West Palm Beach, Florida, United States
    • Indiana
      • Evansville, Indiana, United States
      • Fort Wayne, Indiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Mississippi
      • Olive Branch, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
    • New York
      • Poughkeepsie, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
      • Salem, Oregon, United States
    • Virginia
      • Ettrick, Virginia, United States
    • Wisconsin
      • Middleton, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: 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.
Drug: 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.
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.
Drug: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12
Time Frame: Baseline, Week 12
The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction.
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's control over ejaculation on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who reported at least a 2-category increase in control over ejaculation is provided in the table below.
At the end of treatment (Week 12)
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 Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who achieved 1-category or greater decrease (improvement) in personal distress related to the speed of ejaculation is provided in the table below.
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 Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation and control over ejaculation on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who reported a composite score of at least a 2-category increase in control over ejaculation and at least a 1-category decrease (improvement) in personal distress is provided in the table below.
At the end of treatment (Week 12)
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 Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who achieved 1-category or greater increase in satisfaction with sexual intercourse is provided in the table below.
Endpoint (After 12 weeks of treatment)
The Percentage of Patients Reporting At Least a "Better" Response to Treatment
Time Frame: Endpoint (After 12 weeks of treatment)
The "Clinical Global Impression of Change" (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from "Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better". The percentage of patients who reported improvement in PE of at least "better" at Endpoint (after 12 weeks of treatment) is provided in the table below.
Endpoint (After 12 weeks of treatment)
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 Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to ejaculation on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who reported at least a 1-category decrease (improvement) in interpersonal difficulty related to ejaculation is provided in the table below.
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)
The "Clinical Global Impression of Change" (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from "Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better". The percentage of patients who reported improvement in PE of at least "slightly better" at Endpoint (after 12 weeks of treatment) is provided in the table below.
Endpoint (After 12 weeks of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016486
  • R096769PRE3008 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
  • 2009-013616-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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