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

NCT04185441 | Completed Phase 3 DMC

• 1 other identifier: EMS0119 - TANZÂNIA
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Tanzânia association in adults with erectile dysfunction associated with Benign Prostatic Hyperplasia.

Conditions

Erectile Dysfunction; Benign Prostatic Hyperplasia

Keywords

Erectile Dysfunction; Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in erectile function questionnaire.

  The erectile function questionnaire score ranges from 1 to 30 points. The lower the score, the higher the degree of erectile dysfunction.

  8 weeks

Secondary Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  10 weeks

Study Arms (2)

TANZÂNIA

EXPERIMENTAL

The study is double-dummy. The patient must take 2 pills, as follow: 1 capsule Tanzânia association, oral, once a day, and 1 tablet tamsulosin placebo, oral, once a day.

Drug: Tanzânia association; Other: Omnic Ocas placebo

Omnic Ocas

ACTIVE COMPARATOR

The study is double-dummy. The patient must take 2 pills, as follow: 1 tablet Omnic Ocas, oral, once a day, and 1 capsule Tanzânia association placebo, oral, once a day.

Drug: Omnic Ocas; Other: Tanzânia association placebo

Interventions

Tanzânia association DRUG

Tanzânia association capsule

TANZÂNIA

Omnic Ocas DRUG

Tamsulosin 0,4 mg

Omnic Ocas

Omnic Ocas placebo OTHER

Tamsulosin placebo

TANZÂNIA

Tanzânia association placebo OTHER

EMS association placebo

Omnic Ocas

Eligibility Criteria

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

You may qualify if:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Male participants aged 18 years or more;
• Sexually active participants with a defined partner who have averaged 1 attempt at sexual intercourse per week in the past month;
• Diagnosis of Benign Prostatic Hyperplasia;
• Diagnosis of erectile dysfunction;
• Patients with score between 6 and 25 points in the erectile function questionnaire;
• IPSS (International Prostate Symptom Score) greater or equal to 8 points;

You may not qualify if:

• Known hypersensitivity to the formula components used during the clinical trial;
• History of alcohol and/or substance abuse within 2 years;
• Diagnosis of other diseases or conditions in the urinary tract, including but not limited to: cancer, neurogenic bladder; urinary incontinence, recurrent infection, urethral stricture, bacterial prostatitis;
• Clinical evidence of prostate cancer;
• Hypogonadism or absent sexual desire;
• Severe psychiatric or psychosocial disorders;
• Primary erectile dysfunction;
• Polyneuropathy, neurodegenerative diseases, trauma or spinal cord injuries, central nervous system tumors or other conditions that may affect erections;
• Anatomical penile deformation that can significantly impair erection, including but not limited to: angulation, cavernous fibrosis, Peyronie's disease.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Allergisa

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: March 14, 2021
• Primary Completion: October 10, 2023
• Study Completion: July 5, 2024
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)