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.
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
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)
Crossover
IncobotulinumtoxinA (100 Units)
DrugIntracavernosal Xeomin
Placebo
Other interventionPlacebo
Tadalafil 20 MG
DrugPDE5 Inhibitor Medication
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
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
Persistence of efficacy in erectile function
Persistence of efficacy in erectile function as measured by the validated IIEF-EF domain (3-6 months in placebo portion of crossover study). This domain provides a score on a scale of 6-30 over a period of time, 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
Persistence of efficacy in erectile hardness
Persistence of efficacy in erectile hardness as measured by the validated erectile hardness scale (EHS) (3-6 months in placebo portion of crossover study). The scale ranges from Grade 0 - Grade 4. It measures the firmness of an erection over a period of time 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
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Northwestern University
Lead sponsor
Merz North America, Inc.
Collaborator
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