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Primary Premature Ejaculation Genetics

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ClinicalTrials.gov Identifier: NCT02109302
Recruitment Status : Unknown
Verified April 2014 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Not yet recruiting
First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Premature Ejaculation Procedure: Blood sample Procedure: Skin biopsy Other: Questionnaire Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Primary Purpose: Basic Science
Official Title: Identification Des Bases moléculaires de l'éjaculation prématurée Primaire
Estimated Primary Completion Date : April 2018



Primary Outcome Measures :
  1. Number of subjects with genetic mutations of susceptibility to primary PE [ Time Frame: 4 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109302


Contacts
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Contact: Guillaume Vogt +33 (0)1 42 75 43 20 guillaume.vogt@inserm.fr

Locations
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France
Polyclinique de Blois Not yet recruiting
La Chaussée Saint Victor, France, 41260
Contact: Benoît Vogt, MD       benoitvogt@free.fr   
Principal Investigator: Benoît Vogt, MD         
Hôpital Saint Joseph Not yet recruiting
Marseille Cedex 08, France, 13285
Contact: Robert Porto, MD       robert.porto@worldonline.fr   
Principal Investigator: Robert Porto, MD         
Hôpital Necker Not yet recruiting
Paris, France, 75015
Contact: Alexandre Alcaïs, MD       alexandre.alcais@inserm.fr   
Principal Investigator: Alexandre Alcaïs, MD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Alexandre Alcaïs, MD Hôpital Necker

Publications:
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02109302     History of Changes
Other Study ID Numbers: C12-32
2012-A01055-38 ( Registry Identifier: ID RCB )
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders