Primary Premature Ejaculation Genetics

Premature Ejaculation Clinical Trial

Official title:

Identification Des Bases moléculaires de l'éjaculation prématurée Primaire

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02109302
• Other study ID #: C12-32
• Secondary ID: 2012-A01055-38
• Status: Not yet recruiting
• Phase: N/A
• First received: April 2, 2014
• Last updated: April 7, 2014

Study information

• Verified date: April 2014
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Guillaume Vogt
• Phone: +33 (0)1 42 75 43 20
• Email: guillaume.vogt[@]inserm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

2.1 Main Objective

• To identify the molecular basis of primary premature ejaculation (PPE) in humans for the development of new adapted therapy.

• Check and confirm the genetic hypothesis of PPE to fill the void of genetic knowledge about this syndrome.

• Improve knowledge of physicians on this disease to increase the comfort of life of patients.

2.2 Secondary Objectives

• Provide the basis for new therapeutic approaches.

• Expanded knowledge of the aetiology of PE and allow better management of patients.

• Develop strategies to prevent the consequences, sometimes severe , of this condition on the intimate, personal, social and professional life of these patients. Because all the PE do not have the same pathophysiology and treatment success depends on its relevance to the specific mechanism of the clinical form concerned.

• Increase the comfort of life of the patients.

• Eliminate public prejudice based on misconceptions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. . 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

2. . 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

Non Inclusion Criteria:

1. . 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

• Person deprived of liberty by judicial or administrative decision

• Major Person subject of legal protection or unable to consent

• Refusal to be informed of an abnormality detected after genetic testing

• History of allergies to lidocaine or other anesthetic agent used during puncture or blood sample

2. . Related :

• Age <18 years

• Inability to receive clear information about the protocol . Unable to participate in the entire study.

• No coverage by the social security system

• Absence of signature of consent or refusal of the related party

• Person deprived of liberty by judicial or administrative decision

• Major Person subject of legal protection or unable to consent

• Refusal to be informed of a genetic abnormality detected

• History of allergies to lidocaine or other anesthetic agent used during puncture or blood sample

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Procedure:
• Blood sample

• Skin biopsy

Other:
• Questionnaire

Locations

Country	Name	City	State
France	Polyclinique de Blois	La Chaussée Saint Victor
France	Hôpital Saint Joseph	Marseille Cedex 08
France	Hôpital Necker	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & 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. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No