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

NCT06264414 | Not Yet Recruiting Phase 3

• 1 other identifier: DTT106-III-0123
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostatic Hyperplasia, Benign; Erectile Dysfunction

Outcome Measures

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.

  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 Outcomes (11)

• Change in maximum urinary flow rate (Qmax)

  baseline and 12 weeks

• Decrease in post-void residual volume (PVR)

  baseline and 12 weeks

• Improvement in urinary symptoms.

  baseline and 12 weeks

• Improvement in urinary emptying symptoms

  baseline and 12 weeks

• Improvement in urinary storage symptoms.

  baseline and 12 weeks

Study Arms (2)

DTT106

EXPERIMENTAL

1 hard capsule once a day, consistently 30 minutes after the same meal each day

Drug: DTT106

dutasteride and tamsulosin

ACTIVE COMPARATOR

1 hard capsule once a day, consistently 30 minutes after the same meal each day

Drug: Dutasteride-Tamsulosin

Interventions

DTT106 DRUG

oral route

DTT106

Dutasteride-Tamsulosin DRUG

oral route

dutasteride and tamsulosin

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

EMS

Hortolândia, São Paulo, Brazil

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Cassiano Berto

CONTACT

+551938877724; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

BR (1)