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Showing 1-18 of 18 trials
NCT07434271
This is a Phase 2a, double-blind, placebo-controlled, crossover study evaluating the efficacy, safety, and patient-reported outcomes of KH-001 in men with lifelong premature ejaculation (LPE). Approximately 40 participants will receive KH-001 or placebo in two 4-week treatment periods separated by a washout.
NCT07236632
Premature ejaculation (PE) is one of the most common male sexual dysfunctions, often resistant to conventional pharmacological and behavioral treatments. This randomized clinical trial aims to compare the safety and efficacy of two minimally invasive treatment options - hyaluronic acid (HA) injection into the glans penis versus botulinum toxin type A injection into the bulbospongiosus muscle - in men with lifelong drug-resistant premature ejaculation. Eighty participants will be randomly assigned in a 1:1 ratio to receive either HA or botulinum toxin injection. The primary outcome is change in intravaginal ejaculatory latency time (IELT). Secondary outcomes include changes in Premature Ejaculation Diagnostic Tool (PEDT), Arabic Index of Premature Ejaculation (AIPE) scores, Premature Ejaculation Profile (PEP), patient satisfaction, and treatment-related adverse events during a 12-month follow-up period.
NCT07036497
Aim: To investigate whether intramuscular B12 treatment has an effect on ejaculation in male patients with B12 deficiency. Methods: Male patients who were diagnosed with vitamin B12 deficiency in the internal medicine outpatient clinic between October 2024 and March 2025 and started intramuscular B12 treatment were included in the study. The scores obtained from the self-estimated intravaginal ejaculation latency time (IELT), premature ejaculation diagnostic tool (PEDT) and premature ejaculation profile (PEP) questionnaires reflecting the ejaculatory status of these patients before treatment were recorded. After 3 months of treatment, these scores were re-recorded by phone call. The scores recorded before and after treatment were compared. Results: The study included 54 patients. The mean age of the patients was 43.46±13.3 years, mean pretreatment IELT was 2.4±1.4 min, and mean pre-treatment PEDT score was 11.3±4.8. In both the whole patient group and the premature ejaculation (PE) group, a statistically significant difference was observed in the items of perceived control over ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation from the PEP questionnaire form after treatment, no significant change was found in the item of personal distress related to ejaculation. PEDT scores showed statistically significant improvement after treatment both in the whole patient group and in the PE group. In terms of IELT, no differences was observed in the whole patient group after treatment, whereas statistically significant improvement was observed in the PE group. Conclusion: Intramuscular vitamin B12 may improve ejaculation times and satisfaction levels in patient's questionnaires forms in male patients.
NCT06570135
This is a controlled study of patients with and without primary premature ejaculation. It is based on near-infrared spectroscopy (NIRS) functional brain imaging to detect and compare changes in brain activity in resting and task states (Simulated Sex) between the two groups of patients.
NCT02109302
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.
NCT06571318
The current study focuses on clinical validation of efficacy of nutraceutical product in management of male health. In healthy adult men with induced premature ejaculation, the introduction of these nutraceuticals has been associated with notable improvements in quality of life. These supplements help them for enhanced sexual satisfaction, increased control over ejaculation, and a reduction in performance anxiety. The psychological benefits are significant, as the improvement in sexual function can lead to higher self-confidence and a more positive outlook on life.
NCT05964608
Premature ejaculation involves not only sexual problems but also relationship and communication difficulties, and behavioral approaches to the treatment of premature ejaculation are promising.
NCT05183334
Premature Ejaculation (PE) is a common sexual dysfunction that has a negative impact on both sex partners. Several lines of treatment have been proposed for the treatment of PE i.e. psychological, behavioral, physiotherapeutic, and pharmacological therapies.Several treatment options have been proposed for treatment of PE including tramadol HCl and PDE5 inhibitors Tramadol HCl is thought to exert its therapeutic action in PE patients
NCT04941690
According to the World Health Organization (WHO) and the World Association for Sexual Health (WAS), sexual health is directly related to everyone's mental health and quality of life. Sexuality is innate to humans and is closely linked to their reproduction. Thus, a correlation between unmet fertility desires and sexual disorders can be observed in infertile couples. In fact, sexual intercourse itself will not be as natural in most cases and will preferentially occur during the "reproductive window". Thus, sexuality will be deprived of recreational and erotic activities, and sexuality will be used only for reproduction. For many men, sexual intercourse will become coercive, repetitive and mechanical, offering little emotion. The interactions between infertility and wife recurrent miscarriage in sexuality are numerous and complex. Many men will perceive their infertility as a loss of masculinity and virility and may feel low self-esteem and depression, in addition, Decreased sperm quality may lead to anxiety in men, which may eventually lead to temporary Sexual Dysfunction (SD).Therefore, the need to identify SD and its severity is crucial for infertile men before receiving individualized male treatment.
NCT03942367
Multi-center, international, prospective, randomized, double-blind, two-arms, sham-controlled, first-in-human clinical investigation. The Patients will be allocated to one of the following groups: * Group A (Active Device Group): Patients will receive a fully functioning vPatch device, pre-configured to deliver stimulation intensity according to the subjective motor threshold intensity reported by the Patients. Pre-configured stimulation intensity cannot be changed by the Patient. * Group B (Sham Device Group): Patients will receive a vPatch device pre-configured to deliver the sensory electrical stimulation according to the subjective sensory threshold that is ineffective for muscle activation. Pre-configured stimulation intensity cannot be changed by the Patient. The study will start with a Screening Visit (Visit 1), when potential Patients complaining of PE will be informed about the investigation and its objectives. If they agree to participate, after signing a valid Informed Consent Form they will undergo a full medical history and physical examination and will be selected according to eligibility criteria except IELT (which will be examined at the next visit). The primary objective of this study is to assess the safety profile of the vPatch device and its effectiveness in delaying ejaculation when used in Patients suffering of PE. The secondary objectives of this study are: * To assess the Patient's perception of the ease of use of the vPatch device and treatment, through the use of a dedicated questionnaire (Usability Questionnaire). * To assess the Patient's perception of the changes in his Premature Ejaculation Profile (PEP) under different aspects with the use of device, through the use of a dedicated questionnaire (Control and Distress Domains of the Premature Ejaculation Profile (PEP) Questionnaire). * To assess the Patient's perceived intensity of orgasm by using the vPatch device, through the use of a validated tool (Orgasmometer).
NCT04012437
Randomized control trial to determine if we can produce increases in the IELT using a new masturbator electronic in subjects with premature ejaculation in combination with a exercise app, producing improvements in the quality and satisfaction of the sexuality of the patient.
NCT03174470
The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.
NCT02939495
The purpose of this study is to evaluate the efficacy and safety of Dapoxetine/Sildenafil 30/50 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.
NCT01021553
To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men with primary premature ejaculation. An assessment of the safety and tolerability of all doses of GSK557296 will be performed as well as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at the end of the 8 weeks of treatment. During the active treatment period study participants will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both 4 week intervals.
NCT00664365
This study is the first administration of GSK958108 to man. The study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses of GSK958108 and evaluate the effect of food on GSK958108 pharmacokinetics
NCT03177226
Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.
NCT02984592
Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and their partners. The current study was aimed to evaluate the relationship between ejaculation and physical activity.
NCT01901029
To determine the prevalence of sexual problems particularly premature ejaculation and erectile dysfunction among men working in factories of Dongguan city, using the self-rating scales like International Index of Erectile Function, and to investigate the characteristics or risk factors associated with these sexual problems in floating population through regression analysis.