Primary Premature Ejaculation Genetics

Status Not yet recruiting

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02109302
Study type	Interventional
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
Status	Not yet recruiting
Phase	N/A

View Details

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
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
Not yet recruiting	`NCT00656552` - Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation	Phase 0

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.