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Trial record 4 of 23 for:    priligy

The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01063881
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : October 31, 2012
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pte Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sexual Dysfunction, Physiological
Intervention Drug: Dapoxetine
Enrollment 285
Recruitment Details A total of 285 patients were enrolled in the study, of which 281 patients received at least 1 dose of study drug were included in the safety analysis set (Dapoxetine 30 mg only [144 patients], Dapoxetine 30 t0 60 mg [124 patients] and Dapoxetine 30 to 60 to 30 mg [13 patients]).
Pre-assignment Details  
Arm/Group Title Dapoxetine 30 mg Only Dapoxetine 30 to 60 mg Dapoxetine 30 to 60 to 30 mg
Hide Arm/Group Description Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
Period Title: Overall Study
Started 147 125 13
Completed 92 114 12
Not Completed 55 11 1
Reason Not Completed
Adverse Event             12             2             0
Lost to Follow-up             13             7             1
Withdrawal by Subject             25             1             0
Reason for not completed not specified             5             1             0
Arm/Group Title Dapoxetine 30 mg Only Dapoxetine 30 to 60 mg Dapoxetine 30 to 60 to 30 mg Total
Hide Arm/Group Description 144 of 147 patients took at least 1 dose of dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. 124 of 125 patients took at least one dose of dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. 13 patients took at least one dose of dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 144 124 13 281
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants 124 participants 13 participants 281 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
142
  98.6%
121
  97.6%
13
 100.0%
276
  98.2%
>=65 years
2
   1.4%
3
   2.4%
0
   0.0%
5
   1.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 144 participants 124 participants 13 participants 281 participants
45.5  (10.43) 46.9  (10.47) 41.1  (7.77) 45.9  (10.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants 124 participants 13 participants 281 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
144
 100.0%
124
 100.0%
13
 100.0%
281
 100.0%
Baseline BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/cm^2
Number Analyzed 144 participants 124 participants 13 participants 281 participants
24.7  (2.79) 25.3  (3.20) 23.9  (2.78) 24.9  (2.99)
1.Primary Outcome
Title The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment
Hide Description The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?” The number of patients who described improvement with their PE of at least "slightly better" after 12 weeks of treatment with dapoxetine are provided in the table below.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.
Arm/Group Title Dapoxetine (Week 12)
Hide Arm/Group Description:
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Overall Number of Participants Analyzed 257
Measure Type: Number
Unit of Measure: Patients
228
2.Secondary Outcome
Title The Patient's Level of Control Over Ejaculation
Hide Description The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of control over intercourse on a 5-point scale. Patients were asked: "Over the past month, was your level of control over ejaculation Very poor, Poor, Fair, Good, or Very Good?” The number of patients who rated their level of control over ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.
Arm/Group Title Dapoxetine (Baseline) Dapoxetine (Week 12)
Hide Arm/Group Description:
Baseline measures were taken before administration of treatment.
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Overall Number of Participants Analyzed 274 278
Measure Type: Number
Unit of Measure: Patients
Very poor 120 22
Poor 132 57
Fair 20 77
Good 2 101
Very good 0 21
3.Secondary Outcome
Title The Patient's Level of Satisfaction With 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. Patients were asked: "Over the past month, was your satisfaction with sexual intercourse Very poor, Poor, Fair, Good, or Very Good?” The number of patients who rated their level of satisfaction with control over ejaculation at before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.
Arm/Group Title Dapoxetine (Baseline) Dapoxetine (Week 12)
Hide Arm/Group Description:
Baseline measures were taken before administration of treatment.
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Overall Number of Participants Analyzed 274 278
Measure Type: Number
Unit of Measure: Patients
Very poor 63 14
Poor 152 40
Fair 53 89
Good 6 105
Very good 0 30
4.Secondary Outcome
Title The Patient's Level of Personal Distress Related to the Speed of 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. Patient's were asked: "Over the past month, how distressed were you by how fast you ejaculated during sexual intercourse? Not at all, A little bit, Moderately, Quite a bit, Extremely." The number of patients who rated their level of personal distress related to the speed of ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.
Arm/Group Title Dapoxetine (Baseline) Dapoxetine (Week 12)
Hide Arm/Group Description:
Baseline measures were taken before administration of treatment.
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Overall Number of Participants Analyzed 274 278
Measure Type: Number
Unit of Measure: Patients
Not at all 2 66
A little bit 32 89
Moderately 32 66
Quite a bit 140 40
Extremely 68 17
5.Secondary Outcome
Title The Patient's Degree of Interpersonal Difficulty Related to the Speed of 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 the speed of ejaculation. Patient's were asked: "Over the past month, to what extent did how fast you/your partner ejaculated during sexual intercourse cause difficulty in your relationship with your partner? Not at all, A little bit, Moderately, Quite a bit, or Extremely?" The number of patients who rated their level of interpersonal difficulty before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.
Arm/Group Title Dapoxetine (Baseline) Dapoxetine (Week 12)
Hide Arm/Group Description:
Baseline measures were taken before administration of treatment.
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Overall Number of Participants Analyzed 274 278
Measure Type: Number
Unit of Measure: Patients
Not at all 12 87
A little bit 40 82
Moderately 78 65
Quite a bit 113 37
Extremely 31 7
6.Secondary Outcome
Title Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Hide Description The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?” The number of patients reporting improvement in their PE by category of the CGIC scale after 12 weeks of treatment with dapoxetine are provided in the table below.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.
Arm/Group Title Dapoxetine (Week 12)
Hide Arm/Group Description:
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Overall Number of Participants Analyzed 257
Measure Type: Number
Unit of Measure: Patients
Much worse 0
Worse 0
Slightly worse 4
No change 25
Slightly better 94
Better 101
Much better 33
7.Secondary Outcome
Title The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage)
Hide Description The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment by the dose of dapoxetine they received in the study. This was a single-arm, open-label, non-randomized study in which “subgroup by dosage” was categorized based on dose-titration patterns observed during the course of the treatment period.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.
Arm/Group Title Dapoxetine 30 mg Only Dapoxetine 30 to 60 mg Dapoxetine 30 to 60 to 30 mg
Hide Arm/Group Description:
Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
Overall Number of Participants Analyzed 141 124 13
Measure Type: Number
Unit of Measure: Patients
109 107 12
8.Secondary Outcome
Title The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type)
Hide Description The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a "slightly better" response to treatment when grouped by type of PE disease (patients with life-long PE and patients with acquired PE). This was a single-arm, open-label, non-randomized study where patients were categorized based their PE disease after enrollment in the study.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.
Arm/Group Title Dapoxetine (Patients With Life-long PE, Week 12) Dapoxetine (Patients With Acquired PE, Week 12)
Hide Arm/Group Description:
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Overall Number of Participants Analyzed 115 163
Measure Type: Number
Unit of Measure: Patients
95 133
9.Secondary Outcome
Title The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT])
Hide Description The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a "slightly better" response to treatment when grouped by intravaginal ejaculation latency time (patients with an IELT of < 1 minute and patients with an IELT of > 1 minute). This was a single-arm, open-label, non-randomized study where patients were categorized based on IELT after enrollment in the study.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.
Arm/Group Title Dapoxetine (Patients With IELT <1 Minute, Week 12) Dapoxetine (Patients With IELT >1 Minute, Week 12)
Hide Arm/Group Description:
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
Overall Number of Participants Analyzed 138 140
Measure Type: Number
Unit of Measure: Patients
110 118
Time Frame Adverse events were reported for the duration of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Depoxetine (DPX) 30 mg Only Depoxetine (DPX) 30 to 60 mg Depoxetine (DPX) 30 to 60 to 30 mg
Hide Arm/Group Description Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
All-Cause Mortality
Depoxetine (DPX) 30 mg Only Depoxetine (DPX) 30 to 60 mg Depoxetine (DPX) 30 to 60 to 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Depoxetine (DPX) 30 mg Only Depoxetine (DPX) 30 to 60 mg Depoxetine (DPX) 30 to 60 to 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/144 (1.39%)   0/124 (0.00%)   0/13 (0.00%) 
Injury, poisoning and procedural complications       
Facial Bones Fracture * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Road Traffic Accident * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Nervous system disorders       
Dizziness * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Depoxetine (DPX) 30 mg Only Depoxetine (DPX) 30 to 60 mg Depoxetine (DPX) 30 to 60 to 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   62/144 (43.06%)   57/124 (45.97%)   12/13 (92.31%) 
Cardiac disorders       
Atrial Fibrillation * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Palpitations * 1  4/144 (2.78%)  3/124 (2.42%)  0/13 (0.00%) 
Ear and labyrinth disorders       
Vertigo * 1  0/144 (0.00%)  0/124 (0.00%)  1/13 (7.69%) 
Eye disorders       
Blepharitis * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Conjunctivitis * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Dry Eye * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Gastrointestinal disorders       
Abdominal Discomfort * 1  0/144 (0.00%)  3/124 (2.42%)  0/13 (0.00%) 
Abdominal Distension * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Abdominal Pain * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Diarrhoea * 1  0/144 (0.00%)  4/124 (3.23%)  1/13 (7.69%) 
Dry Mouth * 1  3/144 (2.08%)  4/124 (3.23%)  0/13 (0.00%) 
Gastrointestinal Disorder * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Nausea * 1  14/144 (9.72%)  18/124 (14.52%)  6/13 (46.15%) 
Vomiting * 1  2/144 (1.39%)  0/124 (0.00%)  0/13 (0.00%) 
General disorders       
Asthenia * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Chest Discomfort * 1  1/144 (0.69%)  1/124 (0.81%)  0/13 (0.00%) 
Chest Pain * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Fatigue * 1  2/144 (1.39%)  3/124 (2.42%)  0/13 (0.00%) 
Feeling Abnormal * 1  1/144 (0.69%)  0/124 (0.00%)  1/13 (7.69%) 
Local Swelling * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Sensation of Foreign Body * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Thirst * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Infections and infestations       
Bronchitis * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Chronic Sinusitis * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Ear Infection Fungal * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Herpes Zoster * 1  1/144 (0.69%)  1/124 (0.81%)  0/13 (0.00%) 
Influenza * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Latent Syphilis * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Nasopharyngitis * 1  1/144 (0.69%)  1/124 (0.81%)  0/13 (0.00%) 
Otitis Media * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Upper Respiratory Tract Infection * 1  0/144 (0.00%)  3/124 (2.42%)  0/13 (0.00%) 
Injury, poisoning and procedural complications       
Lumbar Vertebral Fracture * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Upper Limb Fracture * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Investigations       
Aspartate Aminotransferase Increased * 1  3/144 (2.08%)  0/124 (0.00%)  0/13 (0.00%) 
Blood Bilirubin Increased * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Blood Pressure Increased * 1  1/144 (0.69%)  1/124 (0.81%)  0/13 (0.00%) 
Gamma-Glutamyltransferase Increased * 1  1/144 (0.69%)  1/124 (0.81%)  0/13 (0.00%) 
Metabolism and nutrition disorders       
Hypokalaemia * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain * 1  2/144 (1.39%)  1/124 (0.81%)  0/13 (0.00%) 
Nervous system disorders       
Akathisia * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Burning Sensation * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Dizziness * 1  13/144 (9.03%)  13/124 (10.48%)  6/13 (46.15%) 
Headache * 1  13/144 (9.03%)  12/124 (9.68%)  1/13 (7.69%) 
Mental Impairment * 1  1/144 (0.69%)  1/124 (0.81%)  0/13 (0.00%) 
Paraesthesia * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Somnolence * 1  5/144 (3.47%)  4/124 (3.23%)  0/13 (0.00%) 
Psychiatric disorders       
Anxiety * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Dissociation * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Insomnia * 1  2/144 (1.39%)  1/124 (0.81%)  0/13 (0.00%) 
Libido Decreased * 1  1/144 (0.69%)  1/124 (0.81%)  1/13 (7.69%) 
Renal and urinary disorders       
Proteinuria * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Reproductive system and breast disorders       
Erectile Dysfunction * 1  2/144 (1.39%)  0/124 (0.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchial Hyperreactivity * 1  0/144 (0.00%)  1/124 (0.81%)  0/13 (0.00%) 
Oropharyngeal Pain * 1  0/144 (0.00%)  2/124 (1.61%)  0/13 (0.00%) 
Rhinitis Allergic * 1  0/144 (0.00%)  2/124 (1.61%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders       
Hyperhidrosis * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Rash Papular * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Skin Wrinkling * 1  1/144 (0.69%)  0/124 (0.00%)  0/13 (0.00%) 
Vascular disorders       
Flushing * 1  1/144 (0.69%)  1/124 (0.81%)  0/13 (0.00%) 
Hot Flush * 1  3/144 (2.08%)  1/124 (0.81%)  0/13 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
“Subgroup by dosage” was categorized based on dose-titration patterns observed during the course of the treatment period. Patients were not randomized to treatment by dosage group, disease type, or Intravaginal Ejaculation Latency Time.
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
Name/Title: Sr. Director CDTL, RA CVM Urology
Organization: Janssen Research & Development, LLC
Phone: 1 908 704-4648
Responsible Party: Johnson & Johnson Pte Ltd
ClinicalTrials.gov Identifier: NCT01063881     History of Changes
Other Study ID Numbers: CR016561
R096769PRE3009 ( Other Identifier: Johnson & Johnson Pte Ltd )
PASSION ( Other Identifier: Johnson & Johnson Pte Ltd )
First Submitted: February 4, 2010
First Posted: February 5, 2010
Results First Submitted: August 1, 2012
Results First Posted: October 31, 2012
Last Update Posted: February 4, 2013