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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

Tracking Information
First Submitted Date  ICMJE April 2, 2014
First Posted Date  ICMJE April 9, 2014
Last Update Posted Date April 9, 2014
Study Start Date  ICMJE Not Provided
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Primary Premature Ejaculation Genetics
Official Title  ICMJE Identification Des Bases moléculaires de l'éjaculation prématurée Primaire
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Basic Science
Condition  ICMJE Premature Ejaculation
Intervention  ICMJE
  • Procedure: Blood sample
  • Procedure: Skin biopsy
  • Other: Questionnaire
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 7, 2014)
70
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02109302
Other Study ID Numbers  ICMJE C12-32
2012-A01055-38 ( Registry Identifier: ID RCB )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandre Alcaïs, MD Hôpital Necker
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP