Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02109302
Other study ID # C12-32
Secondary ID 2012-A01055-38
Status Not yet recruiting
Phase N/A
First received April 2, 2014
Last updated April 7, 2014

Study information

Verified date April 2014
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Guillaume Vogt
Phone +33 (0)1 42 75 43 20
Email guillaume.vogt@inserm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date
Est. primary completion date April 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Procedure:
Blood sample

Skin biopsy

Other:
Questionnaire


Locations

Country Name City State
France Polyclinique de Blois La Chaussée Saint Victor
France Hôpital Saint Joseph Marseille Cedex 08
France Hôpital Necker Paris

Sponsors (1)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 years No
See also
  Status Clinical Trial Phase
Completed NCT02232425 - IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE) Phase 2
Completed NCT01439984 - Trial of PED-1 in Male Patients With Premature Ejaculation Phase 3
Completed NCT01203202 - Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation Phase 2
Completed NCT01184105 - A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation Phase 1
Completed NCT03942367 - Evaluation of the Safety and Effectiveness of the vPatch Device N/A
Recruiting NCT06425211 - Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation. N/A
Completed NCT02939495 - The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy Phase 4
Completed NCT02572037 - Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
Recruiting NCT02581826 - Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation Phase 2
Terminated NCT00983736 - Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation Phase 3
Completed NCT00556478 - Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Phase 2/Phase 3
Completed NCT00549211 - A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296. Phase 1
Not yet recruiting NCT05556083 - Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE) Phase 2
Completed NCT03304808 - Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0 N/A
Completed NCT00861484 - Proof of Mechanism in ELT Phase 1
Completed NCT02984592 - Effect of Exercise on Premature Ejaculation N/A
Recruiting NCT02571101 - A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation Phase 2
Completed NCT03174470 - Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle N/A
Completed NCT02794454 - A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health N/A
Completed NCT02297152 - A New Treatment for Premature Ejaculation? N/A