Efficacy of Intracavernosal Xeomin With Tadalafil for Mild-Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study

NCT07537855 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IIT12255
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Erectile Dysfunction

Keywords

xeomin; Incobotulinumtoxin A

Outcome Measures

Primary Outcomes (2)

• Change in erectile function

  1\. Change in erectile function as measured by the validated IIEF-EF domain (3-6 months) following Xeomin portion of the crossover study

  3-6 months

• Change in erectile hardness

  Change in erectile hardness as measured by the validated erectile hardness scale (EHS) (3-6 months) following Xeomin portion of the crossover study

  3-6 months

Secondary Outcomes (2)

• Persistence of efficacy in erectile function

  3-6 monhths

• Persistence of efficacy in erectile hardness

  3-6 months

Study Arms (2)

Xeomin + PDE5i

EXPERIMENTAL

Subjects in this portion of the trial will be administered 20 mg of Tadalafil in conjunction with 100 units of Xeomin

Drug: IncobotulinumtoxinA (100 Units)

Placebo + PDE5i

PLACEBO COMPARATOR

Subjects in this portion of the trial will be administered 20 mg of Tadalafil in conjunction with a placebo

Other: Placebo

Interventions

IncobotulinumtoxinA (100 Units) DRUG

Intracavernosal Xeomin

Xeomin + PDE5i

Placebo OTHER

Placebo

Placebo + PDE5i

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: cisgender men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained from the subject
• History of ED for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" (NIH), the diagnosis of ED has to be confirmed by a physician
• Understanding of study procedures and willingness to abide by all procedures during the course of the study
• Male subject aged ≥18 to ≤ 80 years at visit 1
• Have a monogamous relationship with a female sexual partner (vaginal penetration required for several of the primary efficacy variables) for at least 6 months prior to screening
• Highly motivated to obtain treatment for ED
• History of previous use of at least 1 marketed PDE5 inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose

You may not qualify if:

• Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose)
• BW \<50 kg
• Diagnosis of spinal cord injury
• ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease (e.g., hypopituitarism, hypothyroidism, or hypogonadism)
• History of penile implant.
• The presence of clinically significant penile deformity in the opinion of the investigator.
• Concomitant diagnosis of Peyronie's disease
• Patients with chronic stable angina treated with long-acting nitrates, or patients with chronic stable angina who have required short-acting nitrates in the last 90 days, or angina occurring during sexual intercourse in the last 6 months.
• Patients having met the criteria for unstable angina within 6 months prior to Visit 1, history of myocardial infarction or coronary artery bypass graft surgery within 90 days prior to Visit 1, or percutaneous coronary intervention (e.g., angioplasty or stent placement) within 90 days prior to Visit 1.
• Any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate \>100 bpm) at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia (heart rate \>100 bpm for 30 sec) despite medical or device therapy, or the presence of an automatic internal cardioverter-defibrillator.
• A history of sudden cardiac death (arrest) despite medical or device therapy.
• Any evidence of congestive heart failure within 6 months prior to Visit 1.
• A significant conduction defect within 90 days prior to Visit 1.
• Systolic blood pressure \>170 or \<90 mm Hg or diastolic blood pressure \>100 or \<50 mm Hg at screening (if stress is suspected, retest under basal conditions), or patients with malignant hypertension.
• \<12 weeks since most recent injection of BTX-A/B into any body region for any indication

Sponsors & Collaborators

• Northwestern University: lead
• Merz North America, Inc.: collaborator

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share