Eight Active Men's Sexual Health Clinical Trials Recruiting in the United States

It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today, we feature eight active clinical trials related to men's sexual health topics that are currently recruiting or soon to be recruiting in the United States. Trials are grouped by topic and arranged by start date.

Quick View Table of Featured Men's Sexual Health Clinical Trials

Erectile Dysfunction Clinical Trials

Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

• Sponsor: Tulane University
• Goal:The purpose of the study is to determine the effects of testosterone treatment on erectile function, fatigue, depression, cognitive function, quality of life, urinary incontinence, pain, and damage to neurons in male Multiple Sclerosis patients with low testosterone, using questionnaires, blood samples and a rectal exam in volunteers 55 years and older.
• Intervention: XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector
• Primary Outcome Measures: Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Androgen Deficiency in the Aging Male (ADAM score); Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Sexual Health in Men (SHIM score); Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Male Sexual Health Questionnaire short form (MSHQ-SF).
• Time Frames: Change from baseline to 12 weeks; Change from baseline to 12 weeks; Change from baseline to 12 weeks.
• Study Details
• Source

SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

• Sponsor: Icahn School of Medicine at Mount Sinai
• Goal: Robotic-assisted radical prostatectomy (RALP) has become the standard of care in the management of localized prostate cancer. However, post-prostatectomy erectile dysfunction (ED) and urinary incontinence still pose a challenge that adversely affects the patient's quality of life. Robotic-Assisted Laparoscopic Prostatectomy and SAFE (Saline assisted fascial engorgement) nerve preservation guided by Microultrasound (MUS) is a prospective randomized controlled trial designed to evaluate the impact of normal saline solution hydrodissection (HD) on erectile function outcomes after RALP. 
• Interventions: Robotic-assisted radical prostatectomy, saline assisted fascial engorgement
• Primary Outcome Measure: Sexual Health Inventor for Men
• Time Frame: Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months, and 24-months following surgery.
• Study Details
• Source

4-aminopyridine Treatment for Nerve Injury

• Sponsor: John Elfar
• Goal: To evaluate the role of 4-AP on the recovery of nerve function [the researchers] will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.
• Interventions: 4-Aminopyridine, placebo
• Primary Outcome Measures: Michigan Incontinence Symptom Index (M-ISI)(change over time); International Index of Erectile Function (IIEF)(change over time); Placebo vs. Active Drug Questionnaire. 
• Time Frame: Pre-operative visit, and every seven days (starting after surgery, i.e., seven days post-op) for six months (up to 25 times); Pre-operative visit, and every seven days (starting after surgery, i.e., seven days post-op) for six months (up to 25 times); Through study completion, an average of one year.
• Study Details
• Source

Male Hypogonadism Clinical Trials

Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men

• Sponsor: Azurity Pharmaceuticals
• Goal: A Phase 4, multi-center, open-label, single-arm 24-hour ambulatory blood pressure monitoring (ABPM) study of testosterone cypionate injection in hypogonadal men to assess change in 24-hour ambulatory blood pressure from baseline to end of treatment.
• Interventions: Testosterone Cypionate Injection 200 mg/mL
• Primary Outcome Measure: Number of participants with changes in 24-hour average systolic ambulatory blood pressure.
• Time Frame: From baseline to end of treatment, up to Week 14 (Day 99).
• Study Details
• Source

Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance

• Sponsor: University of Miami
• Goal: The purpose of this study is to evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.
• Interventions: Testosterone cypionate
• Primary Outcome Measure: Proportion of patients with disease progression within 12 months after initiating TRT.
• Time Frame: 12 months.
• Study Details
• Source

52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism

• Sponsor: Halozyme Therapeutics
• Goal: This is a 52-week open label single arm study + 24-Month long-term safety extension to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.
• Interventions: Testosterone enanthate
• Primary Outcome Measure: Increase in testosterone, as evaluated using PK parameters
• Time Frame: From enrollment through end of study assessments at week 53.
• Study Details
• Source

Peyronie's Disease Clinical Trials

Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease

• Sponsor: Charitable Union for the Research and Education of Peyronie’s Disease
• Goal: [The research] team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH. The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to two additional salvage series to determine safety and efficacy compared to historical data.
• Interventions: Collagenase clostridium histolyticum, RestoreX, sildenafil
• Primary Outcome Measures: Penile curvature; Penile length.
• Time Frame: One year; One year.
• Study Details
• Source

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease

• Sponsor: University of Miami
• Goal: The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronie's Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
• Interventions: Collagenase Clostridium Histolyticum
• Primary Outcome Measures: Number of treatment related adverse events; Percent change of penile curvature in degree.
• Time Frames: Up to six months (post-intervention); Baseline up to six months.
• Study Details
• Source

Related Guidelines:

• Male Sexual and Reproductive Health: Male Hypogonadism, Erectile Dysfunction, Premature Ejaculation, and Peyronie’s Disease
  • European Association of Urology (EAU)
  • May 2025

• Erectile Dysfunction
  • American Urological Association (AUA)
  • September 2018

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