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CompletedNCT02109302Updated Mar 14, 2025

Primary Premature Ejaculation Genetics

An interventional study of Blood sample and Skin biopsy in Premature Ejaculation, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 3 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Premature Ejaculation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Men over 18 years of age with primary Premature Ejaculation

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

Interventions

  • ProcedureBlood sample
  • ProcedureSkin biopsy
  • OtherQuestionnaire
05

What researchers measure

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.

    Time frame: 4 years

06

Study locations

3 sites
  • Polyclinique de Blois
    La Chaussée Saint Victor, 41260, France
  • Hôpital Saint Joseph
    Marseille Cedex 08, 13285, France
  • Hôpital Necker
    Paris, 75015, France
07

References and documents

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. French. PubMed 23830259 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT02109302
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Apr 9, 2014
Start date
Apr 2014
Primary completion
Feb 11, 2020
Completion
Feb 11, 2020
Last update
Mar 14, 2025

Study contacts

Alexandre Alcaïs, MD
principal investigator · Hôpital Necker

Oversight

Data monitoring committee
No
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