NCT02984592

Brief Summary

Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and their partners. The current study was aimed to evaluate the relationship between ejaculation and physical activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

December 1, 2016

Last Update Submit

February 2, 2017

Conditions

Keywords

premature ejaculationintravaginal ejaculatory latency timepremature ejaculation diagnostic tools

Outcome Measures

Primary Outcomes (1)

  • intravaginal ejaculatory latency time

    IELT value (second) according to the duration determined by the sexual partner with stopwatch method

    1 month

Secondary Outcomes (1)

  • Premature ejaculation diagnostic tool score

    1 month

Study Arms (2)

Group 1

The participants in group 1 will state that they participate regular exercise programs in the previous 6 months

Behavioral: physical exercise

Group 2

The participants in group 2 will state that they do not perform any regular exercise in previous 6 months.

Interventions

regular exercise programs in the previous 6 months.

Group 1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The participants are 18-45 year-old, and have regular sexual activity for at least 6 months. A comparison was made by metabolic equivalents (MET), premature ejaculation diagnostic tool (PEDT) and intravaginal ejaculatory latency time (IELT).

You may qualify if:

  • year-old
  • sexually active
  • heterosexual,without erectile dysfunction
  • sexual partner for at least six months, and sexual intercourse at least twice a week

You may not qualify if:

  • chronic systemic disorders (such as diabetes or hypertension)
  • use of narcotic/hypnotic drugs or stimulants
  • anabolic steroids
  • selective serotonin receptors inhibitors
  • previous diagnosis and treatment for PE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, 06340, Turkey (Türkiye)

Location

Related Publications (2)

  • Pastore AL, Palleschi G, Leto A, Pacini L, Iori F, Leonardo C, Carbone A. A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine for treatment of lifelong premature ejaculation. Int J Androl. 2012 Aug;35(4):528-33. doi: 10.1111/j.1365-2605.2011.01243.x. Epub 2012 Feb 9.

  • Pastore AL, Palleschi G, Fuschi A, Maggioni C, Rago R, Zucchi A, Costantini E, Carbone A. Pelvic floor muscle rehabilitation for patients with lifelong premature ejaculation: a novel therapeutic approach. Ther Adv Urol. 2014 Jun;6(3):83-8. doi: 10.1177/1756287214523329.

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 7, 2016

Study Start

November 1, 2016

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations