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

National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; Erectile Dysfunction
• Intervention / Treatment: Drug: Tanzânia association; Other: Omnic Ocas placebo; Drug: Omnic Ocas; Other: Tanzânia association placebo

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Allergisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TANZÂNIA; 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; Tanzânia association capsule; Other: Omnic Ocas placebo; Tamsulosin placebo
Active Comparator: Omnic Ocas; 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; Tamsulosin 0,4 mg; Other: Tanzânia association placebo; EMS association placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events recorded during the study.	10 weeks

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2021
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): July 5, 2024

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Benign Prostatic Hyperplasia
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Prostatic Hyperplasia; Erectile Dysfunction
• Other Study ID Numbers: EMS0119 - TANZÂNIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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