Premature EjaculationPhase 1/2LPENCT04850703
Brain Networks Implicated in Lifelong Premature Ejaculation Patients
A Phase 1/2 study testing Transcranial Radom Noise Stimulation and Take Dapoxetine in people with Premature Ejaculation and Sexual Dysfunction, run by Moises Domingo at 1 site in Spain.
Trial summary
Using Brain Mapping and Cognitive ERPs, the investigatos have searched for a Brain Networks involved during Inhibitory Control in Lifelong Premature Ejaculation (LPE) participants. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation, Sexual Dysfunction
- What is being tested?
- Transcranial Radom Noise Stimulation and Take Dapoxetine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2021to 4 Feb 2023
- Phase
- Phase 1/2
- 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 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be over 18 years old and less than 70 years
- Best-practice diagnosed Longlife Premature ejaculation
- Diagnosed since at least one years prior to enrollment.
- No use drugs or medicines
Who cannot join
- Serious visual and hearing loss
- Brain injury following cranial trauma
- Other neurological disorders like Parkinson, ME, headache, etc.
- Birth trauma
- Mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Clinical Response Between tDCS and Dapoxetine, Define a Very Effective Therapeutic Target, That Improves the LPE in the Medium Long Term
Using Brain Mapping and Cognitive ERPs, the investigatos have searched for a Brain Networks involved during Inhibitory Control in Lifelong Premature Ejaculation (LPE) participants. The investigators have designed a clinical trial comparing placebo with tDCS and blacebo group against Dapoxetine, studying the effects on LPE, as well as side effects and their medium and long-term duration.
Read the detailed description
Lifelong premature ejaculation (LPE) is a very common male sexual dysfunction like erectile dysfunction. It produces great distress to sexual harmony and even fertility. Previous neurophysiology studies revealed an ejaculation-related control mechanism in the brain: left inferior frontal gyrus (IFG) activation during successful inhibition. If we use the left IFG as a seed, participants showed weaker resting-state functional connectivity (FC) activity, between the seed and two areas (left dentate nucleus (DN) and right frontal pole) compared with controls.
The main goal is to compare whether the brain biomarker only exists in participants with LPD and how it responds to treatment with Dapoxetine and with tDCS against the IFG networks and lDN, measuring the connectivity changes in these brain networks and FC.
- Conditions
- Premature Ejaculation, Sexual Dysfunction
- Being tested
- Transcranial Radom Noise Stimulation, Take Dapoxetine, Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants, Compare LPE EEG endophenotype between participants and healthy controls
- Keywords
- Brain Mapping, EEG, ERP, tDCS, tRNS, Dapoxetine, Lifelong premature ejaculation, central inhibitory network function, inferior frontal gyrus, dentate nucleus, right frontal pole, Resting State Networks, Funtional connectivity
- Medical subject headings
- Premature Ejaculation, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Radom Noise StimulationDevice
Also called tRNS
tRNS against Dapoxetine in LPE patients
Take DapoxetineDrug
Dapoxetine against tRNS in LPE patients
Comparation EEG changes between Sham Group against tRNS and Dapoxetin participantsCombination product
Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.
Compare LPE EEG endophenotype between participants and healthy controlsDiagnostic test
Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype
| Study group | Role | What they receive |
|---|---|---|
| Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex | Experimental | Participants receive tRNS (weak currents < 2 mA) sessions at IFG brain cortex for 25 minutes 2 times a day 3 times per week during 3 weeks.
After 4 hours they end the last session, a new brain mapping is performed. Receives: Device: Transcranial Radom Noise Stimulation |
| Premature Ejaculation participants who take Dapoxetine | Active comparator | Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping Receives: Drug: Take Dapoxetine |
| Placebo Group | Sham comparator | Participants who do not take medication or receive tRNS sessions Receives: Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants |
| Controls | Other | 44 Healthy humans not clinically not diagnosed with LPD and withouth expression the LPE endophenotype. In this way, the investigators what would be the patients diagnosed clinically with LPE who present the endophenotype or neurophysiological biomarker of LPE. Receives: Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wavelet Changes define Brain Biomarker of LPE
The investigators will reported changes in wavelet (time-frequencies) in Left Prefrontal Lobe F3, F7 and Fz electrodes.
Measured: 1 month
EEG coherence comparing Dapoxetine against tRNS
The investigators will reported changes in brain connectivity comparing taking Dapoxetine with the use of tRNS, calculating EEG coherence.
Measured: 2-3 months
Adverse events comparing Dapoxetine against tRNS
Report adverse events during the application of the protocol Dapoxetine / tRNS.
Measured: 2-3 months
Secondary outcomes (2)
Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls
Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in Dapoxetine group against controls.
Measured: 1 month
Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls
Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in tRNS group against controls.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start2 Feb 2021
- Primary completion21 May 2022
- Study completion4 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moises Domingo
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Alejandro Molina Cabeza, Susana Ferrandis Martinez
- Responsible party
- Sponsor-investigator, Moises Domingo, Spanish Foundation for Neurometrics Development
- Investigators
- Alejandro Molina Cabeza, MD, Principal investigator, Sexual Salud Valclinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850703
- Sponsor's protocol ID
- 0104201UR
- Acronym
- LPE
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Clinical Response Between tDCS and Dapoxetine, Define a Very Effective Therapeutic Target, That Improves the LPE in the Medium Long Term
- ClinicalTrials.gov ID
- NCT04850703
- Acronym / sponsor ID
- LPE / 0104201UR
- Conditions
- Premature Ejaculation, Sexual Dysfunction
- Keywords
- Brain Mapping, EEG, ERP, tDCS, tRNS, Dapoxetine, Lifelong premature ejaculation, central inhibitory network function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Moises DomingoUniversity, hospital or other
- Collaborators
- Dr. Alejandro Molina Cabeza, Susana Ferrandis Martinez
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 21 May 2022 (actual)
- Study completion
- 4 Feb 2023 (actual)
- First posted
- 20 Apr 2021 (actual)
- 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.
Using Brain Mapping and Cognitive ERPs, the investigatos have searched for a Brain Networks involved during Inhibitory Control in Lifelong Premature Ejaculation (LPE) participants. The investigators have designed a clinical trial comparing placebo with tDCS and blacebo group against Dapoxetine, studying the effects on LPE, as well as side effects and their medium and long-term duration.
Detailed description
Lifelong premature ejaculation (LPE) is a very common male sexual dysfunction like erectile dysfunction. It produces great distress to sexual harmony and even fertility. Previous neurophysiology studies revealed an ejaculation-related control mechanism in the brain: left inferior frontal gyrus (IFG) activation during successful inhibition. If we use the left IFG as a seed, participants showed weaker resting-state functional connectivity (FC) activity, between the seed and two areas (left dentate nucleus (DN) and right frontal pole) compared with controls.
The main goal is to compare whether the brain biomarker only exists in participants with LPD and how it responds to treatment with Dapoxetine and with tDCS against the IFG networks and lDN, measuring the connectivity changes in these brain networks and FC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex | Experimental | Device: Transcranial Radom Noise StimulationParticipants receive tRNS (weak currents < 2 mA) sessions at IFG brain cortex for 25 minutes 2 times a day 3 times per week during 3 weeks. After 4 hours they end the last session, a new brain mapping is performed. |
| Premature Ejaculation participants who take Dapoxetine | Active comparator | Drug: Take DapoxetineParticipants take 1 tablet of the drug between 1 and 3 hours before the brain mapping |
| Placebo Group | Sham comparator | Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participantsParticipants who do not take medication or receive tRNS sessions |
| Controls | Other | Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls44 Healthy humans not clinically not diagnosed with LPD and withouth expression the LPE endophenotype. In this way, the investigators what would be the patients diagnosed clinically with LPE who present the endophenotype or neurophysiological biomarker of LPE. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be over 18 years old and less than 70 years
- Best-practice diagnosed Longlife Premature ejaculation
- Diagnosed since at least one years prior to enrollment.
- No use drugs or medicines
Key exclusion criteria (5 listed)
- Serious visual and hearing loss
- Brain injury following cranial trauma
- Other neurological disorders like Parkinson, ME, headache, etc.
- Birth trauma
- Mental retardation
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 |
|---|---|---|
| Transcranial Radom Noise StimulationAlso: tRNStRNS against Dapoxetine in LPE patients | Device | Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex |
| Take DapoxetineDapoxetine against tRNS in LPE patients | Drug | Premature Ejaculation participants who take Dapoxetine |
| Comparation EEG changes between Sham Group against tRNS and Dapoxetin participantsCompare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups. | Combination product | Placebo Group |
| Compare LPE EEG endophenotype between participants and healthy controlsDefine as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype | Diagnostic test | Controls |
Primary outcome
Wavelet Changes define Brain Biomarker of LPE
Time frame: 1 month
The investigators will reported changes in wavelet (time-frequencies) in Left Prefrontal Lobe F3, F7 and Fz electrodes.
EEG coherence comparing Dapoxetine against tRNS
Time frame: 2-3 months
The investigators will reported changes in brain connectivity comparing taking Dapoxetine with the use of tRNS, calculating EEG coherence.
Adverse events comparing Dapoxetine against tRNS
Time frame: 2-3 months
Report adverse events during the application of the protocol Dapoxetine / tRNS.
2 secondary outcomes
Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls
Time frame: 1 month
Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls
Time frame: 1 month
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 12 Apr 2023.
- Sexual Valclinic health InstituteLink provided by the sponsor.
- Urology Department Hereford HospitalLink provided by the sponsor.
- 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.
Alejandro Molina Cabeza, MD principal investigator
Sexual Salud Valclinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial Radom Noise Stimulation and Take Dapoxetine in people with Premature Ejaculation and Sexual Dysfunction, run by Moises Domingo at 1 site in Spain.
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 4 inclusion and 5 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wavelet Changes define Brain Biomarker of LPE (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.