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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04185441

Enrollment

295

Registered

2019-12-04

Start date

2021-03-14

Completion date

2024-07-05

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Erectile Dysfunction

Keywords

Erectile Dysfunction, Benign Prostatic Hyperplasia

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.

Interventions

DRUGTanzânia association

Tanzânia association capsule

DRUGOmnic Ocas

Tamsulosin 0,4 mg

OTHEROmnic Ocas placebo

Tamsulosin placebo

OTHERTanzânia association placebo

EMS association placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in erectile function questionnaire.	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

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026