Primary Premature Ejaculation Genetics

NCT02109302 | Completed

• 2 other identifiers: C12-322012-A01055-38
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

The main objective of our study is to identify the first genetic etiology of primary Premature Ejaculation (PE). We will test and evaluate the existence of genetic determinism conferring susceptibility to a life-long syndrome (primary premature ejaculation) in some patients. To this end, we plan to establish a collection of biological samples and a database of patients with this extreme syndrome, which we will analyze by Genome Wide analysis. This will lead to improvements in the biological understanding, the "knowledge" of physicians of the disease, and should improve the patients' quality of life. Not all PE cases have the same physiopathology and treatment efficiency, which depend on the specific mechanism involved in the clinical context. Our work will make it possible to develop new therapeutic approaches suitable for a large proportion of individuals presenting PE. This integrative approach combining researchers, patients and ethics committees will facilitate profound reflection, promoting the creation of suitable structures capable of receiving patients for appropriate consultations. This unique study of PE should also favor industrial partnerships.

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• Number of subjects with genetic mutations of susceptibility to primary PE

  We will perform WES (Whole Exome Sequencing) to identify shared defective genes in 20 patients. In case of genetic uniformity and of a genetically homogeneous recruitment, we hope to highlight such a gene in several individuals. As primary PE are very rare, this group should have defective genes at much higher frequencies than in the control population (NCBI, 1000 genome and housing-genome). This will allow us to identify genetic mutations of susceptibility to primary PE.

  4 years

Study Arms (1)

Men over 18 years of age with primary Premature Ejaculation

EXPERIMENTAL

Procedure: Blood sample; Procedure: Skin biopsy; Other: Questionnaire

Interventions

Blood sample PROCEDURE

Men over 18 years of age with primary Premature Ejaculation

Skin biopsy PROCEDURE

Men over 18 years of age with primary Premature Ejaculation

Questionnaire OTHER

Men over 18 years of age with primary Premature Ejaculation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (index cases ) Prospective and retrospective cases
• Man aged over 18 years
• signing the informed consent
• Presenting primary PE
• have an affiliation to a social security system
• Related
• Male or female over 18 years
• be related to the index case
• signing the informed consent
• have an affiliation to a social security system
• Patients ( index case ) :
• Be aged under 18
• have known genetic variations that predispose or can promote psychological disorders that can lead to PE ( eg: Kallman 's Syndrome , micropenis , testicular dysgenesis , Klinfelter syndrome, Leydig cell hypoplasia )
• have had psycho- social and psycho- traumatic factors in childhood
• Inability to receive clear information on the protocol

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (3)

Polyclinique de Blois

La Chaussée-Saint-Victor, 41260, France

Location

Hôpital Saint Joseph

Marseille, 13285, France

Location

Hôpital Necker

Paris, 75015, France

Location

Related Publications (1)

• Porto R, Giuliano F. [Premature ejaculation]. Prog Urol. 2013 Jul;23(9):647-56. doi: 10.1016/j.purol.2013.01.005. Epub 2013 Mar 1. French.

  PMID: 23830259 BACKGROUND

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alexandre Alcaïs, MD

  Hôpital Necker

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: March 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)