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

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

  Change in erectile function as measured by the validated IIEF-EF domain (3-6 months) following Xeomin portion of the crossover study. This domain provides a score on a scale of 6-30, where scores can be interpreted as follows: * 26-30: No Erectile Dysfunction * 22-25: Mild Erectile Dysfunction * 17-21: Mild to Moderate Erectile Dysfunction * 11-16: Moderate Erectile Dysfunction * 6-10: Severe Erectile Dysfunction

  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. The scale ranges from Grade 0 - Grade 4. It measures the firmness of an erection using the following grade interpretation: * Grade 0: Penis does not enlarge. * Grade 1: Penis is larger, but not hard. * Grade 2: Penis is hard, but not hard enough for penetration. * Grade 3: Penis is hard enough for penetration, but not completely hard. * Grade 4: Penis is completely hard and fully rigid

  3-6 months

Secondary Outcomes (2)

• Persistence of efficacy in erectile function

  3-6 months

• 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); Drug: Tadalafil 20 MG

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; Drug: Tadalafil 20 MG

Interventions

IncobotulinumtoxinA (100 Units) DRUG

Intracavernosal Xeomin

Xeomin + PDE5i

Tadalafil 20 MG DRUG

PDE5 Inhibitor Medication

Placebo + PDE5i; 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

Related Publications (8)

• Abou Zahr R, Bou Kheir G, Mjaess G, Jabbour T, Chalhoub K, Diamand R, Roumeguere T. Intra-Cavernosal Injection of Botulinum Toxin in the Treatment of Erectile Dysfunction: a Systematic Review and Meta-Analysis. Urology. 2022 Dec;170:5-13. doi: 10.1016/j.urology.2022.08.039. Epub 2022 Sep 15.

  PMID: 36115427 BACKGROUND

• Giuliano F, Joussain C, Denys P, Laurin M, Behr-Roussel D, Assaly R. Intracavernosal OnabotulinumtoxinA Exerts a Synergistic Pro-Erectile Effect When Combined With Sildenafil in Spontaneously Hypertensive Rats. J Sex Med. 2022 Jun;19(6):899-906. doi: 10.1016/j.jsxm.2022.03.213. Epub 2022 Mar 29.

  PMID: 35365400 BACKGROUND

• Giuliano F, Joussain C, Denys P. Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport(R)) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction-Case Studies. Toxins (Basel). 2019 May 21;11(5):283. doi: 10.3390/toxins11050283.

  PMID: 31117236 BACKGROUND

• Giuliano F, Joussain C, Denys P. Long Term Effectiveness and Safety of Intracavernosal Botulinum Toxin A as an Add-on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 Injections for Erectile Dysfunction. J Sex Med. 2022 Jan;19(1):83-89. doi: 10.1016/j.jsxm.2021.10.011. Epub 2021 Dec 20.

  PMID: 34937674 BACKGROUND

• Giuliano F, Denys P, Joussain C. Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin(R)) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series. Toxins (Basel). 2022 Apr 16;14(4):286. doi: 10.3390/toxins14040286.

  PMID: 35448895 BACKGROUND

• Giuliano F, Denys P, Joussain C. Safety and Effectiveness of Repeated Botulinum Toxin A Intracavernosal Injections in Men with Erectile Dysfunction Unresponsive to Approved Pharmacological Treatments: Real-World Observational Data. Toxins (Basel). 2023 Jun 5;15(6):382. doi: 10.3390/toxins15060382.

  PMID: 37368683 BACKGROUND

• Lowe G, Bahnson R. Non-invasive management of primary phosphodiesterase type 5 inhibitor failure in patients with erectile dysfunction. Ther Adv Urol. 2009 Dec;1(5):235-42. doi: 10.1177/1756287210362069.

  PMID: 21789070 BACKGROUND

• Burnett AL, Nehra A, Breau RH, Culkin DJ, Faraday MM, Hakim LS, Heidelbaugh J, Khera M, McVary KT, Miner MM, Nelson CJ, Sadeghi-Nejad H, Seftel AD, Shindel AW. Erectile Dysfunction: AUA Guideline. J Urol. 2018 Sep;200(3):633-641. doi: 10.1016/j.juro.2018.05.004. Epub 2018 May 7.

  PMID: 29746858 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

incobotulinumtoxinA; Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

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: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share