---
title: Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
nct_id: NCT04185441
overall_status: COMPLETED
phase: PHASE3
sponsor: EMS
study_type: INTERVENTIONAL
primary_condition: Erectile Dysfunction
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04185441.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04185441"
ct_last_update_post_date: 2025-12-08
last_seen_at: "2026-05-12T06:20:40.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

**Official Title:** 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

**NCT ID:** [NCT04185441](https://clinicaltrials.gov/study/NCT04185441)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 295
- **Lead Sponsor:** EMS
- **Conditions:** Erectile Dysfunction, Benign Prostatic Hyperplasia
- **Start Date:** 2021-03-14
- **Completion Date:** 2024-07-05
- **CT.gov Last Update:** 2025-12-08

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.
- **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.

## Interventions

- **Tanzânia association** (DRUG) — Tanzânia association capsule
- **Omnic Ocas** (DRUG) — Tamsulosin 0,4 mg
- **Omnic Ocas placebo** (OTHER) — Tamsulosin placebo
- **Tanzânia association placebo** (OTHER) — EMS association placebo

## Primary Outcomes

- **Change from baseline in erectile function questionnaire.** _(time frame: 8 weeks)_ — The erectile function questionnaire score ranges from 1 to 30 points. The lower the score, the higher the degree of erectile dysfunction.

## Secondary Outcomes

- **Incidence and severity of adverse events recorded during the study.** _(time frame: 10 weeks)_

## Locations (1)

- Allergisa, Campinas, São Paulo, Brazil

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.allergisa|campinas|são paulo|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04185441.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04185441*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*