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

September 4, 2017 updated by: Muhammet Fatih Kilinc, Ankara Training and Research Hospital

The Impact and Benefit of Physical Activity on Premature Ejaculation: Results of a Prospective, Randomized, Placebo-controlled Trial

The purpose of this study is to investigate the relationship between physical activity and PE, and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Sexually active, heterosexual patients without regular physical activity or erectile dysfunction, and had a sexual partner for at least six months, and sexual intercourse at least twice a week

Exclusion Criteria:

  • Use of medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases, use of alcohol or addictive substances, or use of drugs that might affect erection and ejaculation, presence of patients with Peyronie's disease, chronic prostatitis, urethritis, or active urinary tract infection, and absence of regular physical activity or previous treatment for premature ejaculation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dapoxetine 30 mg
Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)
Drug: 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
EXPERIMENTAL: Moderate Running
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. (Minimally active category)
Behavioral: 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_COMPARATOR: Sham-controlled
Patients who have sedentary life style will be advised those to walk (not running )at most 30 minutes for 5 days in a week. (Inactive category)
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature Ejaculation Diagnostic Tool (Total Score)
Time Frame: Baseline and 30 Days
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.
Baseline and 30 Days
Intravaginal Ejaculatory Latency Time
Time Frame: Baseline and 30 Days
Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)
Baseline and 30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (ESTIMATE)

July 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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