Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02984592
Other study ID # 5006
Secondary ID
Status Completed
Phase N/A
First received December 1, 2016
Last updated February 2, 2017
Start date November 2016
Est. completion date January 31, 2017

Study information

Verified date February 2017
Source Ankara Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Premature ejaculation (PE) is the most frequent sexual dysfunction in males, and its prevalence has been reported as 21-33%. Currently, there are no universal criteria for the diagnosis, or treatment strategies or approaches for PE. Lack of observational studies directed to PE makes comprehension of this sexual dysfunction difficult. The common point for definition of PE is a short duration between penetration and ejaculation, little or no control on voluntary control of ejaculation, and annoying character and negative effect of this condition on the individual. There are various treatment methods since ejaculation physiology and neuroanatomy is not yet clearly demonstrated. According to neurobiological hypothesis of Waldinger, a dysfunction in the serotonin pathway of the central system such as serotonin-2C hyposensitivity and/or serotonin-1A receptor hypersensitivity is a possible cause of lifelong PE. These experimental animal models showed that serotonergic activity at hypothalamic level inhibited ejaculation reflex. Based on this physiological effect, selective serotonin reuptake inhibitors (SSRI), and serotonin agonists increase intravaginal ejaculation latency time (IELT). A number of studies showed that exercise increased the functional effect of serotonin in the human brain.

The effects of physical activity level on human health have attracted interest worldwide. Lack of physical activity forms the basis of various health problems, however regular physical act contributes prevention and treatment of a number of disorders.

In current study, investigators will compare the ejaculation control, IELT, and prevalence of PE between sportsmen that have regular physical activity, and the individuals with a sedentary lifestyle.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 31, 2017
Est. primary completion date January 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 18-45-year-old

- sexually active

- heterosexual,without erectile dysfunction

- sexual partner for at least six months, and sexual intercourse at least twice a week

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
physical exercise
regular exercise programs in the previous 6 months.

Locations

Country Name City State
Turkey Ankara Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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: 10.1177/17 — View Citation

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: 10.11 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary intravaginal ejaculatory latency time IELT value (second) according to the duration determined by the sexual partner with stopwatch method 1 month
Secondary Premature ejaculation diagnostic tool score Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, score 8 indicates no premature ejaculation, scores 9 and 10 indicate possible premature ejaculation, and scores equal or higher than 11 indicates premature ejaculation. 1 month
See also
  Status Clinical Trial Phase
Completed NCT02232425 - IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE) Phase 2
Completed NCT01439984 - Trial of PED-1 in Male Patients With Premature Ejaculation Phase 3
Completed NCT01203202 - Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation Phase 2
Completed NCT01184105 - A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation Phase 1
Completed NCT03942367 - Evaluation of the Safety and Effectiveness of the vPatch Device N/A
Completed NCT02939495 - The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy Phase 4
Completed NCT02572037 - Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
Recruiting NCT02581826 - Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation Phase 2
Terminated NCT00983736 - Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation Phase 3
Completed NCT00549211 - A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296. Phase 1
Completed NCT00556478 - Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Phase 2/Phase 3
Not yet recruiting NCT05556083 - Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE) Phase 2
Completed NCT03304808 - Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0 N/A
Completed NCT00861484 - Proof of Mechanism in ELT Phase 1
Recruiting NCT02571101 - A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation Phase 2
Completed NCT03174470 - Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle N/A
Completed NCT02794454 - A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health N/A
Completed NCT02297152 - A New Treatment for Premature Ejaculation? N/A
Not yet recruiting NCT00656552 - Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation Phase 0
Recruiting NCT04703127 - Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone. Phase 3