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Tests treatment safety and results for Premature Ejaculation
Official title Effectiveness and Safety of TENS Therapy for Premature Ejaculation
ClinicalTrials.gov ID: NCT06425224
What this study is testing
What is Standard treatment (dapoxetine 30 mg as needed)?
Standard treatment (dapoxetine 30 mg as needed) is an investigational medicine, being studied as a potential treatment for premature ejaculation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is: Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 62, men only
You may be able to join if
- Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual...
- Age between 18 and 62 years.
- PEDT score greater than 11.
- Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study.
- Sexual activity at least once a week.
You likely can't join if
- IIEF-EF score less than 26.
- Glaucoma
- Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or...
- History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
- History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive-compulsive...
- Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
See the full eligibility criteria
- Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the...
- Age between 18 and 62 years.
- PEDT score greater than 11.
- Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study.
- Sexual activity at least once a week.
- Minimum chronicity of PD of 6 months.
- Voluntary participation in the study.
- Signing of the informed consent prior to participation in the study.
- IIEF-EF score less than 26.
- Glaucoma
- Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological.
- History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
- History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive-compulsive disorder, post-traumatic stress disorder, psychiatric disorder, reported...
- Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
- Treatment for PE in the last 3 months.
- Treatment for epileptic syndromes or Parkinson's disease.
- Use of pacemaker or cardiac defibrillator.
- Skin lesions in the area where the electrodes are placed.
- Abuse or dependence on psychoactive substances: alcohol, hallucinogenic drugs.
- Couple who are pregnant or interested in conceiving a pregnancy in the next 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 62 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.