Premature EjaculationNCT02109302
Primary Premature Ejaculation Genetics
A study testing Blood sample, Skin biopsy and Questionnaire in people with Premature Ejaculation, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Blood sample, Skin biopsy and Questionnaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2014to 11 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . 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
- . Related
Show all 29Show fewer
- 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:
- . 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
- . 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Polyclinique de Blois
La Chaussée-Saint-Victor, 41260
Hôpital Saint Joseph
Marseille, 13285
Hôpital Necker
Paris, 75015
About this study
Official title: Identification Des Bases moléculaires de l'éjaculation prématurée Primaire
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.
- Conditions
- Premature Ejaculation
- Being tested
- Blood sample, Skin biopsy, Questionnaire
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Skin biopsyProcedure or surgery
QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Men over 18 years of age with primary Premature Ejaculation | Experimental | Not described Receives: Procedure: Blood sample; Procedure: Skin biopsy; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alexandre Alcaïs, MD, Principal investigator, Hôpital Necker
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109302
- Sponsor's protocol ID
- C12-32
- Other IDs
- 2012-A01055-38
- Status last verified
- Jan 2025
- First submitted
- 2 Apr 2014
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification Des Bases moléculaires de l'éjaculation prématurée Primaire
- ClinicalTrials.gov ID
- NCT02109302
- Acronym / sponsor ID
- C12-32
- Conditions
- Premature Ejaculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Apr 2014 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men over 18 years of age with primary Premature Ejaculation | Experimental | Procedure: Blood sample, Procedure: Skin biopsy, Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- . Patients (index cases ) Prospective and retrospective cases
- . Related
- . Patients ( index case ) :
- . Related :
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample | Procedure or surgery | Men over 18 years of age with primary Premature Ejaculation |
| Skin biopsy | Procedure or surgery | Men over 18 years of age with primary Premature Ejaculation |
| Questionnaire | Other | Men over 18 years of age with primary Premature Ejaculation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 23830259Porto 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.
- Individual participant dataSharing planned: No
Related trials for Premature Ejaculation
Not yet recruiting
Male Pelvic Floor Muscle Rehabilitation Exercises
Erectile Dysfunction, Urinary Incontinence
RecruitingObservational study
Ejaculatory and Orgasmic Dysfunction Registry
Ejaculatory Dysfunction, Premature Ejaculation
RecruitingPhase 2
Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
Premature Ejaculation
Not yet recruitingPhase 2
Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
Premature Ejaculation
Recruiting
Pelvic Floor Therapies for Lifelong Premature Ejaculation
Premature Ejaculation, Lifelong Premature Ejaculation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Alcaïs, MD principal investigator
Hôpital Necker
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, Skin biopsy and Questionnaire in people with Premature Ejaculation, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with genetic mutations of susceptibility to primary PE (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.