Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

Phase III, Multicenter, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

The purpose of this study is to assess the safety and efficacy of the DTT106 in the treatment of erectile dysfunction associated with benign prostatic hyperplasia

After being informed about all risks and benefits and giving written informed consent, the subjects will undergo a 7-day screening to determine eligibility. After that, at visit 0 (V0), the subjects will be randomized to either the DTT106 or dutasteride + tamsulosin (0,5 mg + 0,4 mg).

Inclusion Criteria:

• men aged 40 years and older.
• Sexually active men, with a defined partner, who have engaged in an average of 1 attempt at sexual intercourse per week in the last month.
• Participants under stable treatment with dutasteride + tamsulosin combination therapy.
• Diagnosis of erectile dysfunction, according to criteria established by the Guideline of the Brazilian Society of Urology and the American Society of Urology (2017);
• Erectile Function domain score of IIEF ≤ 25 and ≥ 6 points at the time of screening.

Exclusion Criteria:

• Any clinical or physical observation noted during evaluation by the investigating physician, or any laboratory condition, which is interpreted as posing a risk to participation in the clinical trial;
• Presence of uncontrolled chronic diseases;
• History of alcohol or illicit drug use disorder within the past 2 years;
• Men who are planning to impregnate their partners, or fertile men who are not using a reliable contraceptive method;
• Known allergy or hypersensitivity to the components of the medicinal products used during the clinical trial;
• History of pelvic surgery, prostatectomy, radiation therapy, penile implant placement surgery, urinary tract trauma, or invasive procedures for BPH treatment.
• Diagnosis of other diseases or conditions in the urinary tract, including, but not limited to: cancer, neurogenic bladder, urinary incontinence, recurrent infection, urethral stenosis, bacterial prostatitis.
• Clinical evidence of prostate cancer;
• Severe renal failure;
• Severe liver failure;
• Hypogonadism (supported by values below normal, as established by the local laboratory, for total testosterone) or absent libido (sex drive);
• Severe psychiatric or psychosocial disorders;
• Primary erectile dysfunction;
• Polyneuropathy, neurodegenerative diseases, spinal cord trauma or injury, tumors in the central nervous system, or other conditions that may affect erections;
• History of orthostatic hypotension.
• Expected to undergo cataract or glaucoma surgery;
• Concomitant use of any form of organic nitrate;
• Concomitant use of guanylate cyclase stimulators such as riociguat;
• Anatomical deformation of the penis that can significantly impair erection, including, but not limited to: angulation, cavernous fibrosis, and Peyronie's disease.
• Conditions that may predispose to priapism, including but not limited to: sickle cell anemia, multiple myeloma, leukemia;
• Prior diagnosis of pulmonary hypertension;
• Presence of anterior ischemic optic neuropathy, or degenerative diseases of the retina, including retinitis pigmentosa;
• Diagnosis of dysautonomia.
• Cardiovascular disease for which sexual activity is inadvisable, including but not limited to: Myocardial infarction in the last 90 days; Unstable angina or angina that occurs during sexual intercourse; Class 2 or higher heart failure according to the New York Heart Association in the last 6 months; Arrhythmias not controlled; Hypotension (< 90/50 mmHg) or uncontrolled hypertension; Stroke in the last six months.
• Diabetics with HbA1c greater than or equal to 10%, or with a history of retinopathy and/or neuropathy;
• Use of prohibited medications as per the protocol;
• Erectile dysfunction that has not responded to phosphodiesterase inhibitors type 5 (including but not limited to: sildenafil, tadalafil, vardenafil) at the time of screening.
• Participation in clinical trial protocols within the last 12 (twelve) months.