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

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ClinicalTrials.gov Identifier: NCT01063855
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : November 5, 2012
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Erectile Dysfunction
Sexual Dysfunction
Interventions Drug: Placebo
Drug: Dapoxetine
Drug: PDE5I (phosphodiesterase-5 inhibitor)
Enrollment 495
Recruitment Details Study R096769-PRE-3008 was conducted at 69 study centers in 13 countries between 27 April 2010 and 31 August 2011.
Pre-assignment Details Of the 495 randomized patients, 429 patients completed the study, and 66 patients were discontinued from the study. All randomized patients (N=495) were included in the intent-to-treat analysis set of patients for efficacy and safety.
Arm/Group Title PDE5I + PLACEBO PDE5I + DPX
Hide Arm/Group Description 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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. 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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
Period Title: Overall Study
Started 245 250
Completed 208 221
Not Completed 37 29
Reason Not Completed
Adverse Event             4             4
Death             0             1
Lost to Follow-up             8             4
Pregnancy             1             0
Lack of Efficacy             0             1
Withdrawal by Subject             11             8
Reason not specified             13             11
Arm/Group Title PDE5I + PLACEBO PDE5I + DPX Total
Hide Arm/Group Description 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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. 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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. Total of all reporting groups
Overall Number of Baseline Participants 245 250 495
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 250 participants 495 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
228
  93.1%
231
  92.4%
459
  92.7%
>=65 years
17
   6.9%
19
   7.6%
36
   7.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 245 participants 250 participants 495 participants
47.9  (11.96) 49.5  (11.23) 48.7  (11.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 250 participants 495 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
245
 100.0%
250
 100.0%
495
 100.0%
Baseline BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/cm2
Number Analyzed 245 participants 250 participants 495 participants
27.2  (4.50) 27.1  (4.55) 27.2  (4.52)
1.Primary Outcome
Title The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.
Arm/Group Title PDE5I + Placebo (Baseline) PDE5I + Placebo (Week 12) PDE5I + Dapoxetine (Baseline) PDE5I + Dapoxetine (Week 12)
Hide Arm/Group Description:
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
Overall Number of Participants Analyzed 241 230 249 240
Mean (Standard Deviation)
Unit of Measure: minutes
1.1  (0.53) 3.4  (3.54) 1.1  (0.55) 5.2  (5.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PDE5I + Placebo (Baseline), PDE5I + Placebo (Week 12), PDE5I + Dapoxetine (Baseline), PDE5I + Dapoxetine (Week 12)
Comments Null Hypothesis: No difference at Week 12 last postbaseline observations carried forward (LPOCF) Alternative Hypothesis:- Difference at Week 12 LPOCF >0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.
Method ANCOVA
Comments ANCOVA model included treatment, PDE5I stratum, baseline Average IELT stratum, and region, as cofactors and baseline Average IELT as a covariate.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.69
Confidence Interval (2-Sided) 95%
0.837 to 2.542
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.430
Estimation Comments Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm minus PDE5I + Placebo arm difference.
2.Secondary Outcome
Title The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation
Hide Description 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.
Time Frame At the end of treatment (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.
Arm/Group Title PDE5I + Placebo PDE5I + Dapoxetine
Hide Arm/Group Description:
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
Overall Number of Participants Analyzed 229 246
Measure Type: Number
Unit of Measure: Percentage of Patients
32.3 45.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PDE5I + Placebo, PDE5I + Dapoxetine
Comments Null hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF). Alternative hypothesis: Difference at Week 12 LPOCF > 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.6
Confidence Interval (2-Sided) 95%
4.9 to 22.3
Estimation Comments Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + placebo arm.
3.Secondary Outcome
Title The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation
Hide Description 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.
Time Frame At Endpoint (After 12 weeks of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.
Arm/Group Title PDE5I + Placebo PDE5I + Dapoxetine
Hide Arm/Group Description:
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
Overall Number of Participants Analyzed 229 246
Measure Type: Number
Unit of Measure: Percentage of Patients
67.2 76.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PDE5I + Placebo, PDE5I + Dapoxetine
Comments Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.
Method Cochran-Mantel-Haenszel
Comments The Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.2
Confidence Interval (2-Sided) 95%
1.1 to 17.2
Estimation Comments Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + Placebo arm.
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At the end of treatment (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.
Arm/Group Title PDE5I + Placebo PDE5I + Dapoxetine
Hide Arm/Group Description:
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
Overall Number of Participants Analyzed 229 246
Measure Type: Number
Unit of Measure: Percentage of Patients
30.6 43.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PDE5I + Placebo, PDE5I + Dapoxetine
Comments Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis: PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error.
Method Regression, Logistic
Comments Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
1.204 to 2.619
Estimation Comments Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.
5.Secondary Outcome
Title The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse
Hide Description 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.
Time Frame Endpoint (After 12 weeks of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.
Arm/Group Title PDE5I + Placebo PDE5I + Dapoxetine
Hide Arm/Group Description:
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
Overall Number of Participants Analyzed 229 246
Measure Type: Number
Unit of Measure: Percentage of Patients
55.0 66.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PDE5I + Placebo, PDE5I + Dapoxetine
Comments Null Hypothesis: No difference at Week 12 last postbaseline observation carrried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.
Method Regression, Logistic
Comments Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
1.108 to 2.394
Estimation Comments Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.
6.Secondary Outcome
Title The Percentage of Patients Reporting At Least a "Better" Response to Treatment
Hide Description 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.
Time Frame Endpoint (After 12 weeks of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.
Arm/Group Title PDE5I + Placebo PDE5I + Dapoxetine
Hide Arm/Group Description:
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
Overall Number of Participants Analyzed 229 246
Measure Type: Number
Unit of Measure: Percentage of Patients
35.4 56.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PDE5I + Placebo, PDE5I + Dapoxetine
Comments Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate
Method Regression, Logistic
Comments Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.42
Confidence Interval (2-Sided) 95%
1.642 to 3.568
Estimation Comments Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.
7.Secondary Outcome
Title The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation
Hide Description 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.
Time Frame Endpoint (After 12 weeks of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.
Arm/Group Title PDE5I + Placebo PDE5I + Dapoxetine
Hide Arm/Group Description:
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
Overall Number of Participants Analyzed 229 246
Measure Type: Number
Unit of Measure: Percentage of Patients
61.6 67.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PDE5I + Placebo, PDE5I + Dapoxetine
Comments Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.
Method Regression, Logistic
Comments Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.897 to 1.965
Estimation Comments Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.
8.Secondary Outcome
Title The Percentage of Patients Reporting At Least a "Slightly Better" Response to Treatment
Hide Description 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.
Time Frame Endpoint (After 12 weeks of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.
Arm/Group Title PDE5I + Placebo PDE5I + Dapoxetine
Hide Arm/Group Description:
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
Overall Number of Participants Analyzed 230 240
Measure Type: Number
Unit of Measure: Percentage of Patients
66.9 91.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PDE5I + Placebo, PDE5I + Dapoxetine
Comments Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.
Method Regression, Logistic
Comments Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.21
Confidence Interval (2-Sided) 95%
1.425 to 3.423
Estimation Comments Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.
Time Frame Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PDE5I + PLACEBO PDE5I + DPX
Hide Arm/Group Description 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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. 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 + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
All-Cause Mortality
PDE5I + PLACEBO PDE5I + DPX
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PDE5I + PLACEBO PDE5I + DPX
Affected / at Risk (%) Affected / at Risk (%)
Total   4/245 (1.63%)   3/250 (1.20%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/245 (0.00%)  1/250 (0.40%) 
Cardiac disorders     
Myocardial Infarction * 1  0/245 (0.00%)  1/250 (0.40%) 
Musculoskeletal and connective tissue disorders     
Juvenile Arthritis * 1  1/245 (0.41%)  0/250 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Meningioma * 1  1/245 (0.41%)  0/250 (0.00%) 
Renal Cell Carcinoma * 1  1/245 (0.41%)  0/250 (0.00%) 
Nervous system disorders     
Syncope * 1  0/245 (0.00%)  1/250 (0.40%) 
Renal and urinary disorders     
Renal Colic * 1  0/245 (0.00%)  1/250 (0.40%) 
Social circumstances     
Miscarriage of Partner * 1  1/245 (0.41%)  0/250 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PDE5I + PLACEBO PDE5I + DPX
Affected / at Risk (%) Affected / at Risk (%)
Total   45/245 (18.37%)   73/250 (29.20%) 
Cardiac disorders     
Palpitations * 1  0/245 (0.00%)  1/250 (0.40%) 
Congenital, familial and genetic disorders     
Phimosis * 1  1/245 (0.41%)  0/250 (0.00%) 
Ear and labyrinth disorders     
Tinnitus * 1  1/245 (0.41%)  1/250 (0.40%) 
Vertigo * 1  1/245 (0.41%)  4/250 (1.60%) 
Vertigo Positional * 1  1/245 (0.41%)  0/250 (0.00%) 
Eye disorders     
Eye Pain * 1  0/245 (0.00%)  1/250 (0.40%) 
Eyelid Ptosis * 1  0/245 (0.00%)  1/250 (0.40%) 
Vision Blurred * 1  0/245 (0.00%)  1/250 (0.40%) 
Gastrointestinal disorders     
Abdominal Pain * 1  1/245 (0.41%)  0/250 (0.00%) 
Abdominal Pain Upper * 1  1/245 (0.41%)  0/250 (0.00%) 
Diarrhoea * 1  2/245 (0.82%)  9/250 (3.60%) 
Dry Mouth * 1  0/245 (0.00%)  1/250 (0.40%) 
Dyspepsia * 1  1/245 (0.41%)  3/250 (1.20%) 
Flatulence * 1  0/245 (0.00%)  1/250 (0.40%) 
Gastritis * 1  1/245 (0.41%)  1/250 (0.40%) 
Gastrooesophageal Reflux Disease * 1  1/245 (0.41%)  0/250 (0.00%) 
Inguinal Hernia * 1  0/245 (0.00%)  1/250 (0.40%) 
Nausea * 1  3/245 (1.22%)  23/250 (9.20%) 
Toothache * 1  0/245 (0.00%)  2/250 (0.80%) 
Vomiting * 1  1/245 (0.41%)  1/250 (0.40%) 
General disorders     
Adverse Drug Reaction * 1  1/245 (0.41%)  0/250 (0.00%) 
Asthenia * 1  0/245 (0.00%)  1/250 (0.40%) 
Chills * 1  0/245 (0.00%)  1/250 (0.40%) 
Fatigue * 1  1/245 (0.41%)  2/250 (0.80%) 
Irritability * 1  0/245 (0.00%)  1/250 (0.40%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/245 (0.41%)  0/250 (0.00%) 
Infections and infestations     
Bacterial Food Poisoning * 1  0/245 (0.00%)  1/250 (0.40%) 
Ear Infection Viral * 1  1/245 (0.41%)  0/250 (0.00%) 
Gastroenteritis * 1  1/245 (0.41%)  1/250 (0.40%) 
Influenza * 1  1/245 (0.41%)  2/250 (0.80%) 
Lower Respiratory Tract Infection * 1  0/245 (0.00%)  1/250 (0.40%) 
Nasopharyngitis * 1  4/245 (1.63%)  3/250 (1.20%) 
Oral Herpes * 1  1/245 (0.41%)  0/250 (0.00%) 
Pharyngitis * 1  1/245 (0.41%)  2/250 (0.80%) 
Respiratory Tract Infection Viral * 1  1/245 (0.41%)  0/250 (0.00%) 
Upper Respiratory Tract Infection * 1  1/245 (0.41%)  4/250 (1.60%) 
Injury, poisoning and procedural complications     
Arthropod Bite * 1  0/245 (0.00%)  1/250 (0.40%) 
Back Injury * 1  0/245 (0.00%)  1/250 (0.40%) 
Contusion * 1  0/245 (0.00%)  1/250 (0.40%) 
Hand Fracture * 1  1/245 (0.41%)  0/250 (0.00%) 
Joint Injury * 1  0/245 (0.00%)  1/250 (0.40%) 
Joint Sprain * 1  1/245 (0.41%)  0/250 (0.00%) 
Meniscus Lesion * 1  0/245 (0.00%)  1/250 (0.40%) 
Procedural Pain * 1  1/245 (0.41%)  0/250 (0.00%) 
Road Traffic Accident * 1  1/245 (0.41%)  0/250 (0.00%) 
Tendon Rupture * 1  1/245 (0.41%)  0/250 (0.00%) 
Thermal Burn * 1  1/245 (0.41%)  0/250 (0.00%) 
Tooth Fracture * 1  1/245 (0.41%)  0/250 (0.00%) 
Investigations     
Blood Pressure Increased * 1  0/245 (0.00%)  1/250 (0.40%) 
Gastric Ph Decreased * 1  1/245 (0.41%)  0/250 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  0/245 (0.00%)  1/250 (0.40%) 
Hypertriglyceridaemia * 1  0/245 (0.00%)  1/250 (0.40%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/245 (0.41%)  1/250 (0.40%) 
Back Pain * 1  2/245 (0.82%)  1/250 (0.40%) 
Musculoskeletal Chest Pain * 1  1/245 (0.41%)  0/250 (0.00%) 
Musculoskeletal Pain * 1  2/245 (0.82%)  0/250 (0.00%) 
Musculoskeletal Stiffness * 1  1/245 (0.41%)  0/250 (0.00%) 
Myalgia * 1  1/245 (0.41%)  0/250 (0.00%) 
Neck Pain * 1  1/245 (0.41%)  0/250 (0.00%) 
Nervous system disorders     
Disturbance in Attention * 1  0/245 (0.00%)  1/250 (0.40%) 
Dizziness * 1  2/245 (0.82%)  6/250 (2.40%) 
Dizziness Exertional * 1  1/245 (0.41%)  0/250 (0.00%) 
Dizziness Postural * 1  1/245 (0.41%)  6/250 (2.40%) 
Headache * 1  12/245 (4.90%)  11/250 (4.40%) 
Lethargy * 1  0/245 (0.00%)  1/250 (0.40%) 
Sedation * 1  0/245 (0.00%)  1/250 (0.40%) 
Somnolence * 1  1/245 (0.41%)  0/250 (0.00%) 
Syncope * 1  0/245 (0.00%)  1/250 (0.40%) 
Psychiatric disorders     
Agitation * 1  0/245 (0.00%)  1/250 (0.40%) 
Anxiety * 1  0/245 (0.00%)  1/250 (0.40%) 
Euphoric Mood * 1  0/245 (0.00%)  1/250 (0.40%) 
Insomnia * 1  1/245 (0.41%)  3/250 (1.20%) 
Renal and urinary disorders     
Haematuria * 1  1/245 (0.41%)  0/250 (0.00%) 
Micturition Urgency * 1  1/245 (0.41%)  0/250 (0.00%) 
Nephrolithiasis * 1  1/245 (0.41%)  0/250 (0.00%) 
Nocturia * 1  1/245 (0.41%)  0/250 (0.00%) 
Pollakiuria * 1  1/245 (0.41%)  0/250 (0.00%) 
Renal Cyst * 1  1/245 (0.41%)  0/250 (0.00%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia * 1  0/245 (0.00%)  1/250 (0.40%) 
Erectile Dysfunction * 1  1/245 (0.41%)  0/250 (0.00%) 
Penis Disorder * 1  1/245 (0.41%)  0/250 (0.00%) 
Prostatomegaly * 1  1/245 (0.41%)  0/250 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis * 1  0/245 (0.00%)  1/250 (0.40%) 
Hiccups * 1  1/245 (0.41%)  0/250 (0.00%) 
Nasal Congestion * 1  3/245 (1.22%)  0/250 (0.00%) 
Oropharyngeal Pain * 1  0/245 (0.00%)  1/250 (0.40%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  0/245 (0.00%)  1/250 (0.40%) 
Hyperhidrosis * 1  0/245 (0.00%)  3/250 (1.20%) 
Photosensitivity Reaction * 1  1/245 (0.41%)  0/250 (0.00%) 
Pruritus * 1  0/245 (0.00%)  1/250 (0.40%) 
Pruritus Generalised * 1  1/245 (0.41%)  0/250 (0.00%) 
Skin Lesion * 1  0/245 (0.00%)  1/250 (0.40%) 
Vascular disorders     
Flushing * 1  3/245 (1.22%)  0/250 (0.00%) 
Hypertension * 1  0/245 (0.00%)  1/250 (0.40%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CDTL, Cardiovascular and Metabolism
Organization: Janssen Research & Development, LLC
Phone: 1 908 704-4648
Layout table for additonal information
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01063855     History of Changes
Other Study ID Numbers: CR016486
R096769PRE3008 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
2009-013616-12 ( EudraCT Number )
First Submitted: February 4, 2010
First Posted: February 5, 2010
Results First Submitted: October 4, 2012
Results First Posted: November 5, 2012
Last Update Posted: January 24, 2013