Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2014-04-30
2020-02-11
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Men over 18 years of age with primary Premature Ejaculation
Blood sample
Skin biopsy
Questionnaire
Interventions
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Blood sample
Skin biopsy
Questionnaire
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
ALL
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Alexandre Alcaïs, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Necker
Locations
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Polyclinique de Blois
La Chaussée-Saint-Victor, , France
Hôpital Saint Joseph
Marseille, , France
Hôpital Necker
Paris, , France
Countries
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References
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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.
Other Identifiers
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2012-A01055-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
C12-32
Identifier Type: -
Identifier Source: org_study_id
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