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NCT Number: NCT06264414

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

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Key information

Conditions

Prostatic Hyperplasia, Benign Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Prostatic Diseases Prostatic Hyperplasia Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

EMS

Hortolândia, São Paulo, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DTT106

Drug

oral route

Dutasteride-Tamsulosin

Drug

oral route

Primary outcomes

  1. Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline.

    Time frame: baseline and 12 weeks

    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

Secondary outcomes

  1. Change in maximum urinary flow rate (Qmax)

    Time frame: baseline and 12 weeks

    The maximum urinary flow rate (Qmax) will be measured by a flowmeter, compared to the baseline value, at the end of treatment

  2. Decrease in post-void residual volume (PVR)

    Time frame: baseline and 12 weeks

    Change in post-void residual (PVR) volume, measured through prostate ultrasound

  3. Improvement in urinary symptoms.

    Time frame: baseline and 12 weeks

    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.

  4. Improvement in urinary emptying symptoms

    Time frame: baseline and 12 weeks

    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.

  5. Improvement in urinary storage symptoms.

    Time frame: baseline and 12 weeks

    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.

  6. Improvement in the participant's quality of life in relation to their urinary condition

    Time frame: baseline and 12 weeks

    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.

  7. Improvement in the participant's sexual function

    Time frame: baseline and 12 weeks

    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.

  8. Improvement in the participant's orgasmic function.

    Time frame: baseline and 12 weeks

    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.

  9. Effectiveness of the treatment in improving the participant's sexual desire

    Time frame: baseline and 12 weeks

    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.

  10. Effectiveness in improving the participant's satisfaction with sexual relations

    Time frame: baseline and 12 weeks

    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.

  11. Overall satisfaction of the participant regarding their sex life.

    Time frame: baseline and 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cassiano Berto

CONTACT

[email protected]

+551938877724

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Acronym: AUSTRÁLIA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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