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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction; Prostatic Hyperplasia, Benign
• Intervention / Treatment: Drug: DTT106; Drug: Dutasteride-Tamsulosin

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 262
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cassiano Berto; Phone Number: +551938877724; Email: pesquisa.clinica@ncfarma.com.br

Study Locations

• Brazil
  • São Paulo
    • Hortolândia, São Paulo, Brazil
      • EMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DTT106; 1 hard capsule once a day, consistently 30 minutes after the same meal each day	Drug: DTT106; oral route
Active Comparator: dutasteride and tamsulosin; 1 hard capsule once a day, consistently 30 minutes after the same meal each day	Drug: Dutasteride-Tamsulosin; oral route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline.	The IIEF (International Index of Erectile Function) is a quantitative measure used in the diagnostic assessment of erectile dysfunction. The IIEF is the sum of the scores assigned to each question, with scores ranging from 1 to 5, where 1=never and 5=always. The questionnaire covers five domains	baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximum urinary flow rate (Qmax)	The maximum urinary flow rate (Qmax) will be measured by a flowmeter, compared to the baseline value, at the end of treatment	baseline and 12 weeks
Decrease in post-void residual volume (PVR)	Change in post-void residual (PVR) volume, measured through prostate ultrasound	baseline and 12 weeks
Improvement in urinary symptoms.	Change in the total International Prostate Symptom Score (IPSS) in patients.The IPSS relies upon the responses to seven questions regarding urinary symptoms and one question related to the patient's quality of life. Each question about urinary symptoms allows the patient to select one of six responses indicating the severity of the particular symptom. These responses are assigned points from 0 to 5. Consequently, the total score can vary from 0 to 35, with higher scores representing more severe symptoms. A higher score on the IPSS implies a poorer outcome.	baseline and 12 weeks
Improvement in urinary emptying symptoms	Change in the score of the emptying domain of the IPSS (obstructive symptoms, questions 1, 3, 5, and 6). The IPSS relies upon the responses to seven questions regarding urinary symptoms and one question related to the patient's quality of life. Each question about urinary symptoms allows the patient to select one of six responses indicating the severity of the particular symptom. These responses are assigned points from 0 to 5. Consequently, the total score can vary from 0 to 35, with higher scores representing more severe symptoms. A higher score on the IPSS implies a poorer outcome.	baseline and 12 weeks
Improvement in urinary storage symptoms.	Change in the score of the storage domain of the IPSS (irritative symptoms, questions 2, 4, and 7). The IPSS relies upon the responses to seven questions regarding urinary symptoms and one question related to the patient's quality of life. Each question about urinary symptoms allows the patient to select one of six responses indicating the severity of the particular symptom. These responses are assigned points from 0 to 5. Consequently, the total score can vary from 0 to 35, with higher scores representing more severe symptoms. A higher score on the IPSS implies a poorer outcome.	baseline and 12 weeks
Improvement in the participant's quality of life in relation to their urinary condition	Change in the score of the quality-of-life item of the IPSS (IPSS-QoL). The IPSS relies upon the responses to seven questions regarding urinary symptoms and one question related to the patient's quality of life. Each question about urinary symptoms allows the patient to select one of six responses indicating the severity of the particular symptom. These responses are assigned points from 0 to 5. Consequently, the total score can vary from 0 to 35, with higher scores representing more severe symptoms. A higher score on the IPSS implies a poorer outcome.	baseline and 12 weeks
Improvement in the participant's sexual function	Change in the total IIEF score. The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.	baseline and 12 weeks
Improvement in the participant's orgasmic function.	Change in the Orgasmic Function domain of the IIEF (IIEF-OF, questions 9 and 10). The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.	baseline and 12 weeks
Effectiveness of the treatment in improving the participant's sexual desire	Change in the Sexual Desire domain of the IIEF (IIEF-SD, questions 11 and 12). The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.	baseline and 12 weeks
Effectiveness in improving the participant's satisfaction with sexual relations	Change in the Satisfaction domain of Sexual Intercourse of the IIEF (IIEF-IS, questions 6, 7, and 8). The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.	baseline and 12 weeks
Overall satisfaction of the participant regarding their sex life.	Change in the General Satisfaction domain of the IIEF (IIEF-OS, questions 13 and 14). The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.	baseline and 12 weeks

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Prostatic Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Erectile Dysfunction; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; 5-alpha Reductase Inhibitors; Tamsulosin; Dutasteride
• Other Study ID Numbers: DTT106-III-0123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No