Trial Outcomes & Findings for Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction (NCT NCT01063855)

Last Updated: 2013-01-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

495 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2013-01-24

Participant Flow

Study R096769-PRE-3008 was conducted at 69 study centers in 13 countries between 27 April 2010 and 31 August 2011.

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.

Participant milestones

Participant milestones
Measure	PDE5I + PLACEBO 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.	PDE5I + DPX 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 Study STARTED	245	250
Overall Study COMPLETED	208	221
Overall Study NOT COMPLETED	37	29

Reasons for withdrawal

Reasons for withdrawal
Measure	PDE5I + PLACEBO 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.	PDE5I + DPX 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 Study Adverse Event	4	4
Overall Study Death	0	1
Overall Study Lost to Follow-up	8	4
Overall Study Pregnancy	1	0
Overall Study Lack of Efficacy	0	1
Overall Study Withdrawal by Subject	11	8
Overall Study Reason not specified	13	11

Baseline Characteristics

Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PDE5I + PLACEBO n=245 Participants 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.	PDE5I + DPX n=250 Participants 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 n=495 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	228 Participants n=5 Participants	231 Participants n=7 Participants	459 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Age Continuous	47.9 years STANDARD_DEVIATION 11.96 • n=5 Participants	49.5 years STANDARD_DEVIATION 11.23 • n=7 Participants	48.7 years STANDARD_DEVIATION 11.61 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	245 Participants n=5 Participants	250 Participants n=7 Participants	495 Participants n=5 Participants
Baseline BMI	27.2 kg/cm2 STANDARD_DEVIATION 4.50 • n=5 Participants	27.1 kg/cm2 STANDARD_DEVIATION 4.55 • n=7 Participants	27.2 kg/cm2 STANDARD_DEVIATION 4.52 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	PDE5I + Placebo (Baseline) n=241 Participants 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.	PDE5I + Placebo (Week 12) n=230 Participants 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.	PDE5I + Dapoxetine (Baseline) n=249 Participants 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	PDE5I + Dapoxetine (Week 12) n=240 Participants 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
The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12	1.1 minutes Standard Deviation 0.53	3.4 minutes Standard Deviation 3.54	1.1 minutes Standard Deviation 0.55	5.2 minutes Standard Deviation 5.78

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PDE5I + Placebo (Baseline) n=229 Participants 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.	PDE5I + Placebo (Week 12) n=246 Participants 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.	PDE5I + Dapoxetine (Baseline) 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	PDE5I + Dapoxetine (Week 12) 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
The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation	32.3 Percentage of Patients	45.9 Percentage of Patients	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PDE5I + Placebo (Baseline) n=229 Participants 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.	PDE5I + Placebo (Week 12) n=246 Participants 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.	PDE5I + Dapoxetine (Baseline) 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	PDE5I + Dapoxetine (Week 12) 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
The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation	67.2 Percentage of Patients	76.4 Percentage of Patients	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PDE5I + Placebo (Baseline) n=229 Participants 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.	PDE5I + Placebo (Week 12) n=246 Participants 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.	PDE5I + Dapoxetine (Baseline) 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	PDE5I + Dapoxetine (Week 12) 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
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	30.6 Percentage of Patients	43.5 Percentage of Patients	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PDE5I + Placebo (Baseline) n=229 Participants 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.	PDE5I + Placebo (Week 12) n=246 Participants 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.	PDE5I + Dapoxetine (Baseline) 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	PDE5I + Dapoxetine (Week 12) 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
The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse	55.0 Percentage of Patients	66.3 Percentage of Patients	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PDE5I + Placebo (Baseline) n=229 Participants 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.	PDE5I + Placebo (Week 12) n=246 Participants 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.	PDE5I + Dapoxetine (Baseline) 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	PDE5I + Dapoxetine (Week 12) 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
The Percentage of Patients Reporting At Least a "Better" Response to Treatment	35.4 Percentage of Patients	56.5 Percentage of Patients	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PDE5I + Placebo (Baseline) n=229 Participants 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.	PDE5I + Placebo (Week 12) n=246 Participants 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.	PDE5I + Dapoxetine (Baseline) 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	PDE5I + Dapoxetine (Week 12) 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
The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation	61.6 Percentage of Patients	67.5 Percentage of Patients	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PDE5I + Placebo (Baseline) n=230 Participants 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.	PDE5I + Placebo (Week 12) n=240 Participants 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.	PDE5I + Dapoxetine (Baseline) 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	PDE5I + Dapoxetine (Week 12) 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
The Percentage of Patients Reporting At Least a "Slightly Better" Response to Treatment	66.9 Percentage of Patients	91.3 Percentage of Patients	—	—

Adverse Events

PDE5I + PLACEBO

Serious events: 4 serious events

Other events: 45 other events

Deaths: 0 deaths

PDE5I + DPX

Serious events: 3 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PDE5I + PLACEBO n=245 participants at risk 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.	PDE5I + DPX n=250 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/245 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.	0.40% 1/250 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.
Cardiac disorders Myocardial Infarction	0.00% 0/245 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.	0.40% 1/250 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.
Musculoskeletal and connective tissue disorders Juvenile Arthritis	0.41% 1/245 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.	0.00% 0/250 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.41% 1/245 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.	0.00% 0/250 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.41% 1/245 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.	0.00% 0/250 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.
Nervous system disorders Syncope	0.00% 0/245 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.	0.40% 1/250 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.
Renal and urinary disorders Renal Colic	0.00% 0/245 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.	0.40% 1/250 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.
Social circumstances Miscarriage of Partner	0.41% 1/245 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.	0.00% 0/250 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.

Other adverse events

Additional Information

CDTL, Cardiovascular and Metabolism

Janssen Research & Development, LLC

Phone: 1 908 704-4648

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60