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)
Northwestern University
Lead sponsor
Merz North America, Inc.
Collaborator