Erectile Dysfunction

56

Review clinical trials related to Erectile Dysfunction. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Comparison Between Excision And Primary Anastomosis Urethroplasty And Tunica Vaginalis Graft Urethroplasty.

Urethroplasty is considered as a gold standard in treatment of urethral stricture disease having success rate of more than 93% in terms of recurrence of stricture. The objective of the study is to compare the outcome between excision and primary anastomosis (EPA) urethroplasty, a transecting urethroplasty technique and Tunica Vaginalis Graft (TVG) Urethroplasty, a non-transecting urethroplasty technique, in patients with bulbar urethral stricture upto 2cm in length. It will be a Randomized Controlled Trial (RCT) in which 94 patients admitted in Sahiwal Teaching Hospital, Sahiwal will be included. The patients will be divided into two equal groups. Randomization will be performed using a computer-generated random sequence. The Group-A patients will undergo excision and primary anastomosis (EPA) urethroplasty while Group-B patients will undergo Tunica Vaginalis Graft (TVG) Urethroplasty. Non-probability convenience sampling will be carried out. Detailed history of urinary symptoms, Sexual function, catheterization, instrumentation, urinary tract infection and trauma will be taken to obtain the cause of stricture. Demographic information like name, age, and contact number will be recorded. Investigations will include preoperative complete blood count, renal function test, liver function test, urine complete examination, ultrasonogram kidney, ureter and bladder with post void residual volume (PVR) uroflowmetry and retrograde urethrogram for diagnosis and length of stricture. Other parameters of study will be length of hospital stay, postoperative complication such as graft failure, wound infection, urinary tract infection and fistula formation. Data will be collected through proforma, which will be entered and analyzed using statistical package for social sciences version 26.0. For quantitative variables mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. Chi-square test will be used to estimate the association between qualitative variables. An Independent sample t-test will be applied for quantitative variables. P-value \<0.05 will be considered significant. It is anticipated that the Tunica Vaginalis Graft (TVG) Urethroplasty provides better outcome as compared to excision and primary anastomosis (EPA) urethroplasty.

Participants needed: 94
Trial details
Age: 18-50Biological sex: MaleType: InterventionalSponsor: Sahiwal medical college sahiwalUpdated: Jun 25, 2026
Eligibility criteria

Patients with diagnosis of bulbar urethral stricture upto 2cm in length. [+4]

Urethral stricture which is completely obliterated stricture. [+7]

Status: Recruiting

L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction

Erectile dysfunction is a common male sexual health problem that may affect quality of life and sexual relationships. Tadalafil 5 mg once daily is an established oral treatment for erectile dysfunction. L-citrulline is an oral nitric oxide pathway supplement that may improve erectile function by increasing L-arginine availability. This randomized trial will compare three oral treatment regimens in men with mild to moderate erectile dysfunction: L-citrulline 1500 mg/day, tadalafil 5 mg/day, and the combination of L-citrulline 1500 mg/day plus tadalafil 5 mg/day. Participants will receive treatment for 12 weeks and will be followed at baseline, week 4, week 8, and week 12. The primary outcome will be the change in the International Index of Erectile Function-Erectile Function domain score from baseline to 12 weeks. Secondary outcomes will include changes in IIEF-5/SHIM score, Erection Hardness Score, SEP diary outcomes, treatment adherence, adverse events, and treatment discontinuation.

Participants needed: 133
Trial details
Phase: Phase 4Age: 30-70Biological sex: MaleType: InterventionalSponsor: Beni-Suef UniversityUpdated: Jun 12, 2026Locations: 1
Eligibility criteria

Male patients aged 30 to 70 years. [+6]

Severe erectile dysfunction, defined by International Index of Erectile Function... [+12]

Status: Not yet recruiting

Male Pelvic Floor Muscle Rehabilitation Exercises

Phase I G128 Study Objective The ischiocavernosus (IC) and bulbospongiosus (BS) muscles are vital components of the superficial perineal layer, serving as the foundation for male sexual health and performance. These muscles play a primary role in achieving and maintaining erections by compressing the veins to trap blood within the erectile tissues. Furthermore, they are responsible for the rhythmic contractions necessary for ejaculation and the physiological sensations associated with orgasm. Beyond their role in sexual function, these muscles provide critical structural support to the pelvic floor and assist in urinary control. By working in tandem, the IC and BS muscles ensure penile rigidity while stabilizing the surrounding pelvic structures. Maintaining the strength and coordination of these muscles is essential for overall reproductive health and the prevention of pelvic floor dysfunction. The primary objective of this clinical trial is to evaluate the clinical efficacy and therapeutic potential of Exercise G128 in strengthening the male pelvic floor musculature. Furthermore, the study aims to establish a comprehensive safety profile for Exercise G128 during active participation. The research seeks to address the following core investigative questions: To what extent does Exercise G128 improve the tonicity and contractile strength of the IC and BS muscles? What is the incidence and nature of adverse medical events or physiological stressors reported by participants while performing the Exercise G128 protocol? Researchers will conduct a comparative analysis, benchmarking the physiological outcomes of Exercise G128 against existing clinical data regarding the efficacy of traditional Kegel exercises. Participant Requirements: Adhere to a structured regimen, performing Exercise G128 four times weekly over a one-month intervention period. Attend bi-weekly telehealth consultations via video conferencing for supervised clinical assessments, progress monitoring, and physiological testing. Maintain a detailed daily log documenting functional progress, as well as any instances of physical exertion or soreness that necessitated a temporary cessation of the exercise protocol.

Participants needed: 100
Trial details
Age: 18-60Biological sex: MaleType: InterventionalSponsor: Dream Video LLCUpdated: Jun 10, 2026
Eligibility criteria

Men 18 - 60 years of age [+1]

Underlying medical conditions or poor health [+1]

Status: Recruiting

A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction

This is a device study (while the device has been patented and cleared by the FDA, the indication of the use for Erectile Dysfunction has been yet approve). EXSTACY is a study to collect information on which patients who have trouble getting or keeping an erection rigid enough for sex (sometimes known as Erectile Dysfunction or ED) benefit from light intensity shockwave therapy (LI-SWT). LI-SWT is a form of energy transfer to the penis that has been shown to help some men with ED in studies over the past decade. This study will collect information about patients prior to treatment to determine what predicts a good outcome. The investigators hope that this information will help decide which patients are likely to benefit from LI-SWT and which patients should consider other treatments for ED.

Participants needed: 157
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: University of California, San FranciscoUpdated: May 18, 2026Locations: 1
Eligibility criteria

Patient is over the age of 18 [+5]

Placement of a penile prosthesis (malleable or inflatable type) [+2]

Status: Not yet recruiting

Efficacy of Intracavernosal Xeomin With Tadalafil for Mild-Moderate Erectile Dysfunction

Erectile dysfunction (ED) affects approximately 30 million men in the United States and is associated with factors such as aging, smoking, diabetes, hypertension, obesity, and sedentary lifestyle. ED can also negatively impact the quality of life of patients and their partners. Treatment decisions are typically made jointly between patients and their urologists, often starting with less invasive options. Oral phosphodiesterase-5 inhibitors (PDE5 inhibitors), including sildenafil, tadalafil, and vardenafil, are commonly used as first-line therapy. While these medications improve erectile function in many patients, approximately 30-40% do not respond adequately to PDE5 inhibitor therapy alone. Patients who do not achieve sufficient benefit may require additional or more invasive treatment options.

Participants needed: 30
Trial details
Phase: Phase 2Age: 18-80Biological sex: MaleType: InterventionalSponsor: Northwestern UniversityUpdated: May 11, 2026
Eligibility criteria

Written informed consent obtained from the subject [+6]

Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type... [+30]

Status: Recruiting

Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

The purpose of this study is to test two different ways to help men with sexual rehabilitation.

Participants needed: 224
Trial details
Age: 21+Biological sex: MaleType: InterventionalSponsor: Memorial Sloan Kettering Cancer CenterUpdated: Apr 8, 2026Locations: 1
Eligibility criteria

As per medical record, early stage prostate cancer (Pathologic Stage 1/2 with Gl... [+5]

Both cavernous nerves fully resected as per surgery report (nerve sparing score... [+5]

Status: Not yet recruiting

Stem Cells for Erectile Dysfunction Post RALP

This is a phase 1/2 single center, pilot study to assess safety and efficacy of allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) and to evaluate the timing and combination effects of active treatment versus placebo in promoting the recovery of erectile function in patients undergoing radical retropubic prostatectomy (RALP) of localized prostate cancer.

Participants needed: 40
Trial details
Phase: Phase 1, Phase 2Age: 40-70Biological sex: MaleType: InterventionalSponsor: The Methodist Hospital Research InstituteUpdated: Mar 19, 2026Locations: 1
Eligibility criteria

Patients scheduled for RALP with Dr. B. Miles at Houston Methodist. [+12]

Penile anatomical abnormalities (Peyronie's disease) [+6]

Status: Recruiting

The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation

The aim is to investigate the effectiveness of exercise in the treatment of erectile dysfunction and premature ejaculation.

Participants needed: 50
Trial details
Age: 25-45Biological sex: MaleType: InterventionalSponsor: Uskudar UniversityUpdated: Mar 3, 2026Locations: 1
Eligibility criteria

Male individuals aged 25-45 years [+3]

Individuals with a history of surgery in the pelvic region [+4]

Status: Recruiting

Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction

This phase II clinical trial with safety follow-up is designed to evaluate the efficacy and safety of Cellgram-ED (autologous bone marrow-derived mesenchymal stem cells) administered via intracavernous injection in patients with erectile dysfunction after radical prostatectomy.

Participants needed: 32
Trial details
Age: 19-80Biological sex: MaleType: ObservationalSponsor: Pharmicell Co., Ltd.Updated: Feb 24, 2026Locations: 4
Eligibility criteria

Participants who previously participated in the parent clinical trial and receiv... [+1]

Status: Recruiting

Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED

Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.

Participants needed: 98
Trial details
Age: 22-85Biological sex: MaleType: InterventionalSponsor: OHH-MED Medical LtdUpdated: Feb 13, 2026Locations: 7
Eligibility criteria

Adult, heterosexual, males between 22 and 85 years of age [+6]

Castrate and late onset hypogonadism [+14]

Status: Recruiting

EndoPAT Device for Endothelial Dysfunction in ED

To assess endothelial dysfunction in young men (aged 30-50) with vasculogenic ED identified through penile Doppler ultrasound. To evaluate changes in endothelial function using EndoPAT before and 3-6 months after daily low-dose phosphodiesterase type 5 (PDE5) inhibitor therapy. To investigate endothelial function alterations in hypogonadal patients before and 3-6 months after initiating testosterone (T) therapy

Participants needed: 120
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: University of California, IrvineUpdated: Feb 2, 2026Locations: 1
Eligibility criteria

Males 18 years old and above [+1]

Patients without the above criteria

Status: Recruiting

Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.

The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is: What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation? Patients will: * Have an initial consultation of pelvic floor rehabilitation before therapy. * Be given pelvic floor therapy. * Have a secondary consultation of pelvic floor rehabilitation after therapy. Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.

Participants needed: 66
Trial details
Age: 18-100Biological sex: MaleType: InterventionalSponsor: Boston Medical GroupUpdated: Jan 23, 2026Locations: 1
Eligibility criteria

Men over 18 years of age [+7]

Pharmacological treatment for erectile dysfunction or premature ejaculation in t... [+10]

Status: Recruiting

The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men.

The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function.

Participants needed: 30
Trial details
Age: 18-32Biological sex: MaleType: InterventionalSponsor: Montefiore Medical CenterUpdated: Jan 23, 2026Locations: 1
Eligibility criteria

Subject provides written informed consent and HIPAA authorization in English bef... [+20]

Relevant dietary allergy [+26]

Status: Recruiting

Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain

The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.

Participants needed: 186
Trial details
Age: 40+Biological sex: MaleType: InterventionalSponsor: The Cleveland ClinicUpdated: Jan 21, 2026Locations: 1
Eligibility criteria

Cis-gendered heterosexual adult males18 years old [+5]

Nerve-injury related ED (/spinal cord injury, severe lumbosacral disorder (radic... [+22]

Status: Recruiting

Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D?

males with diabetes complain impotence in the presence of low vitamin D deficiency. pharacmological treatment of low vitamin D levels is necessary but changing lifestyle by performing exercise is also important

Participants needed: 40
Trial details
Age: 35-45Biological sex: MaleType: InterventionalSponsor: Cairo UniversityUpdated: Jan 26, 2026Locations: 1
Eligibility criteria

diabetic men (forty) [+3]

cardiac patients [+3]

Status: Not yet recruiting

Primary Care ERectile Function Outcome Registry for Men

The PERFORM registry is a structured, real-world data platform designed to systematically capture patient characteristics, disease severity and treatment patterns of Erectile Dysfunction (ED) across Pakistan. By reflecting routine clinical practice, an ED registry provides valuable insights into the disease epidemiology, unmet needs, and variations in care across populations. It supports evidence-based decision-making, helps identifying early predictors, and inform guideline development, health policy, and personalized management strategies in male sexual health.

Participants needed: 255
Trial details
Age: 18+Biological sex: MaleType: ObservationalSponsor: Nabiqasim Industries (Pvt) LtdUpdated: Jan 21, 2026Duration: 12 Months
Eligibility criteria

Adult male above 18 years of age [+4]

If at any other PDE-5 inhibitor (sildenafil, tadalafil, vardenafil, avanafil) [+9]

Status: Recruiting

External Device for Erectile Dysfunction (3D-Erect)

The aim of this clinical trial is to test the safety and feasibility of a non-invasive 3D-printed external penile device to achieve successful and satisfactory sexual intercourse in men with erectile dysfunction (ED).

Participants needed: 9
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Stanford UniversityUpdated: Jan 13, 2026Locations: 1
Eligibility criteria

males >18 years old suffering from any cause moderate to severe erectile dysfunc... [+1]

not willing to attempt sexual vaginal intercourse with their partner [+1]

Status: Recruiting

Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.

Participants needed: 60
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Mayo ClinicUpdated: Jan 7, 2026Locations: 1
Eligibility criteria

Palpable penile plaque [+4]

Prior intralesional injections or surgery for PD. [+6]

Status: Not yet recruiting

Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction

The goal of this clinical trial is to Investigate the Effect of Injection of MSC-Derived Exosome on Patients with Erectile Dysfunction in overall healthy males, aged 18-70, with-out any severe active medical condition, with moderate to severe erectile dysfunction based on IIEF-5, and non-satisfactory response to other treatments (5PDEI). The main question it aims to answer is: • Is MSC-derived exosome safe and effective in treating patients with ED by improving IIEF-5 score? If there is a comparison group: Researchers will compare the intervention group (Exosome receiving group) with control group (placebo receiving group) to see if exosomes are safe and effective in treating male adult patients with moderate-sever ED. Participants will receive six weekly injections of normal saline or exosome (based on group), and will undergo necessarily follow up, and examinations and observation.

Participants needed: 70
Trial details
Phase: Phase 2Age: 18-70Biological sex: MaleType: InterventionalSponsor: Labbafinejad Medical CenterUpdated: Jan 6, 2026Locations: 1
Eligibility criteria

Not listed

Status: Not yet recruiting

Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction

This is a randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of YN001 in patients with atherosclerotic cardiovascular and cerebrovascular diseases and erectile dysfunction

Participants needed: 40
Trial details
Phase: Phase 2Age: 18-75Biological sex: MaleType: InterventionalSponsor: Beijing Inno Medicine Co., Ltd.Updated: Dec 30, 2025
Eligibility criteria

Fully understand the purpose, nature, method and possible adverse reactions of t... [+3]

Patients with erectile dysfunction caused by other sexual dysfunction diseases (... [+13]

Status: Not yet recruiting

Effect of Moderate Alcohol on Absorption and Onset of Hezkue Sildenafil Suspension

This is a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects. Participants will receive Hezkue® under different alcohol intake conditions in randomized sequence. Pharmacokinetic sampling and onset assessments will be performed after each administration, and safety will be monitored throughout the study.

Participants needed: 36
Trial details
Phase: Phase 2Age: 18-70Biological sex: MaleType: InterventionalSponsor: Aspargo Labs, IncUpdated: Dec 18, 2025
Eligibility criteria

Male adults 21 to 65 years of age, inclusive [+7]

Known hypersensitivity or contraindication to sildenafil, other PDE5 inhibitors,... [+12]

Status: Not yet recruiting

Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject

The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions. The main questions it aims to answer are: Do Hezkue and Hezkue Turbo differ in absorption compared to other commercial sildenafil products? Are there any differences in safety or tolerability between the products? Researchers will compare multiple formulations to evaluate differences in drug absorption and side effects.

Participants needed: 72
Trial details
Phase: Phase 1Age: 18-70Biological sex: MaleType: InterventionalSponsor: Aspargo Labs, IncUpdated: Dec 12, 2025Locations: 1
Eligibility criteria

Participant must be informed of the nature of the study and voluntarily agree to... [+4]

Unwilling or unable to comply with study procedures. [+31]

Status: Recruiting

Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)

This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation. This study will take approximately 6 months to enroll all subjects. (14 days, 6 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.

Participants needed: 182
Trial details
Age: 22+Biological sex: MaleType: InterventionalSponsor: Rigicon, Inc.Updated: Dec 5, 2025Locations: 7
Eligibility criteria

Male ≥22 years of age. [+3]

1. Contraindication to general anesthesia. [+18]

Status: Not yet recruiting

Phase 2 Efficacy Study of Sildenafil Products in Adult Men With Erectile Dysfunction

The goal of this clinical trial is to learn how different sildenafil-based erectile dysfunction (ED) treatments affect erectile function in adult men. The main questions it aims to answer are: Does each assigned product improve erectile function over 12 weeks? What safety or tolerability issues occur when these products are used on an on-demand basis? Researchers will compare Hezkue® and Hezkue Turbo® with several commercially available sildenafil or sildenafil-plus-tadalafil products to see whether there are differences in effectiveness, treatment experience, or safety. Participants will: * Use one assigned ED treatment on demand for 12 weeks * Complete electronic diaries and questionnaires about sexual-encounter outcomes and treatment satisfaction * Attend study visits for safety checks, laboratory tests, and assessments of erectile function

Participants needed: 200
Trial details
Phase: Phase 2Age: 18-70Biological sex: MaleType: InterventionalSponsor: Aspargo Labs, IncUpdated: Nov 19, 2025
Eligibility criteria

Male, 18 to 70 years of age.

Use of nitrates or nitric oxide donors in any form.

Status: Recruiting

The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects

The objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male subjects

Participants needed: 12
Trial details
Phase: Phase 1Age: 20-70Biological sex: MaleType: InterventionalSponsor: Aspargo Labs, IncUpdated: Nov 19, 2025Locations: 1
Eligibility criteria

The participant must be informed of the nature of the study and voluntarily agre... [+5]

Unwillingness or inability to follow the procedures specified by the protocol. [+35]