Trial Outcomes & Findings for The Impact and Benefit of Physical Activity on Premature Ejaculation (NCT NCT02844998)
NCT ID: NCT02844998
Last Updated: 2017-09-29
Results Overview
Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Baseline and 30 Days
Results posted on
2017-09-29
Participant Flow
Participant milestones
| Measure |
Group 1
Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)
dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries
|
Group 2
Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week.
Physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week (To increase the physical activity level to "minimally active category or moderate physical activities \[600-3,000 MET-min/week\] according to IPAQ classification)
|
Sham-controlled
Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.
physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (inactive category \[\<600 MET-min/week\] according to the IPAQ classification)
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
39
|
39
|
|
Overall Study
COMPLETED
|
35
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=35 Participants
Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)
dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries
|
Group 2
n=35 Participants
Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week
physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week
|
Sham-controlled
n=35 Participants
Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.
physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
Male · <=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=105 Participants
|
|
Age, Categorical
Male · Between 18 and 65 years
|
35 Participants
n=35 Participants
|
35 Participants
n=35 Participants
|
35 Participants
n=35 Participants
|
105 Participants
n=105 Participants
|
|
Age, Categorical
Male · >=65 years
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=105 Participants
|
|
Sex/Gender, Customized
Male
|
35 Participants
n=35 Participants
|
35 Participants
n=35 Participants
|
35 Participants
n=35 Participants
|
105 Participants
n=105 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
35 count of participants
n=35 Participants
|
35 count of participants
n=35 Participants
|
35 count of participants
n=35 Participants
|
105 count of participants
n=105 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30 DaysPremature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.
Outcome measures
| Measure |
Group 1
n=35 Participants
Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)
dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries
|
Group 2
n=35 Participants
Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week.
Physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week (To increase the physical activity level to "minimally active category or moderate physical activities \[600-3,000 MET-min/week\] according to IPAQ classification)
|
Sham-controlled
n=35 Participants
Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.
physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (inactive category \[\<600 MET-min/week\] according to the IPAQ classification)
|
|---|---|---|---|
|
Premature Ejaculation Diagnostic Tool (Total Score)
baseline data
|
14.5 scores on a scale
Standard Deviation 1.9
|
13.7 scores on a scale
Standard Deviation 1.8
|
13.7 scores on a scale
Standard Deviation 2.2
|
|
Premature Ejaculation Diagnostic Tool (Total Score)
end of study data
|
8.9 scores on a scale
Standard Deviation 2.5
|
7.8 scores on a scale
Standard Deviation 2.9
|
12.8 scores on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Baseline and 30 DaysDuration determined by the sexual partner with stopwatch method, and \<1 minute was considered as PE. (minimum/maximum scores were not possible)
Outcome measures
| Measure |
Group 1
n=35 Participants
Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)
dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries
|
Group 2
n=35 Participants
Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week.
Physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week (To increase the physical activity level to "minimally active category or moderate physical activities \[600-3,000 MET-min/week\] according to IPAQ classification)
|
Sham-controlled
n=35 Participants
Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.
physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (inactive category \[\<600 MET-min/week\] according to the IPAQ classification)
|
|---|---|---|---|
|
Intravaginal Ejaculatory Latency Time
baseline data
|
36.8 seconds
Standard Deviation 13.1
|
39.3 seconds
Standard Deviation 8.8
|
33.8 seconds
Standard Deviation 14.7
|
|
Intravaginal Ejaculatory Latency Time
end of study data
|
181.7 seconds
Standard Deviation 88.8
|
188.6 seconds
Standard Deviation 82.9
|
50.3 seconds
Standard Deviation 19.1
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham-controlled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place