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Primary Premature Ejaculation Genetics

Primary Purpose

Premature Ejaculation

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood sample

Skin biopsy

Questionnaire

About this trial

This is an interventional basic science trial for Premature Ejaculation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

. 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

Non Inclusion Criteria:

. 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
. 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

Sites / Locations

Polyclinique de Blois
Hôpital Saint Joseph
Hôpital Necker

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02109302

First Posted

April 2, 2014

Last Updated

April 7, 2014

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

1. Study Identification

Unique Protocol Identification Number

NCT02109302

Brief Title

Primary Premature Ejaculation Genetics

Official Title

Identification Des Bases moléculaires de l'éjaculation prématurée Primaire

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Ejaculation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Blood sample

Intervention Type

Procedure

Intervention Name(s)

Skin biopsy

Intervention Type

Other

Intervention Name(s)

Questionnaire

Primary Outcome Measure Information:

Title

Number of subjects with genetic mutations of susceptibility to primary PE

Description

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: . 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 Non Inclusion Criteria: . 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 . 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guillaume Vogt

Phone

+33 (0)1 42 75 43 20

guillaume.vogt@inserm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre Alcaïs, MD

Organizational Affiliation

Hôpital Necker

Official's Role

Principal Investigator

Facility Information:

Facility Name

Polyclinique de Blois

City

La Chaussée Saint Victor

ZIP/Postal Code

41260

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benoît Vogt, MD

benoitvogt@free.fr

First Name & Middle Initial & Last Name & Degree

Benoît Vogt, MD

Facility Name

Hôpital Saint Joseph

City

Marseille Cedex 08

ZIP/Postal Code

13285

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Porto, MD

robert.porto@worldonline.fr

First Name & Middle Initial & Last Name & Degree

Robert Porto, MD

Facility Name

Hôpital Necker

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandre Alcaïs, MD

alexandre.alcais@inserm.fr

First Name & Middle Initial & Last Name & Degree

Alexandre Alcaïs, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23830259

Citation

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.

Results Reference

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Primary Premature Ejaculation Genetics

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