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Trial record 20 of 23 for:    priligy

The Impact and Benefit of Physical Activity on Premature Ejaculation (PE)

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ClinicalTrials.gov Identifier: NCT02844998
Recruitment Status : Completed
First Posted : July 26, 2016
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Muhammet Fatih Kilinc, Ankara Training and Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Premature Ejaculation
Interventions Behavioral: physical activity
Drug: dapoxetine 30 mg on demand
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2 Sham-controlled
Hide Arm/Group Description

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

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)

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)

Period Title: Overall Study
Started 42 39 39
Completed 35 35 35
Not Completed 7 4 4
Arm/Group Title Group 1 Group 2 Sham-controlled Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 35 35 35 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Male Number Analyzed 35 participants 35 participants 35 participants 105 participants
<=18 years 0 0 0 0
Between 18 and 65 years 35 35 35 105
>=65 years 0 0 0 0
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Male Number Analyzed 35 participants 35 participants 35 participants 105 participants
35 35 35 105
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Count of participants
Turkey Number Analyzed 35 participants 35 participants 35 participants 105 participants
35 35 35 105
[1]
Measure Description: All participitants are male
1.Primary Outcome
Title Premature Ejaculation Diagnostic Tool (Total Score)
Hide Description 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.
Time Frame Baseline and 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Sham-controlled
Hide Arm/Group Description:

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

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)

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 Number of Participants Analyzed 35 35 35
Mean (Standard Deviation)
Unit of Measure: scores on a scale
baseline data 14.5  (1.9) 13.7  (1.8) 13.7  (2.2)
end of study data 8.9  (2.5) 7.8  (2.9) 12.8  (1.7)
2.Primary Outcome
Title Intravaginal Ejaculatory Latency Time
Hide Description Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)
Time Frame Baseline and 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Sham-controlled
Hide Arm/Group Description:

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

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)

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 Number of Participants Analyzed 35 35 35
Mean (Standard Deviation)
Unit of Measure: seconds
baseline data 36.8  (13.1) 39.3  (8.8) 33.8  (14.7)
end of study data 181.7  (88.8) 188.6  (82.9) 50.3  (19.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Sham-controlled
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Group 1 Group 2 Sham-controlled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Sham-controlled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2 Sham-controlled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Muhammet Fatih Kilinc
Organization: Ankara TRH
Phone: +90 312 595 3700 ext 3724
Responsible Party: Muhammet Fatih Kilinc, Ankara Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02844998     History of Changes
Other Study ID Numbers: 5191
First Submitted: July 13, 2016
First Posted: July 26, 2016
Results First Submitted: July 6, 2017
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017