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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-14

Study Completion Date

2024-07-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Erectile Dysfunction Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Tanzânia association

Intervention Type DRUG

Tanzânia association capsule

Omnic Ocas placebo

Intervention Type OTHER

Tamsulosin placebo

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.

Group Type ACTIVE_COMPARATOR

Omnic Ocas

Intervention Type DRUG

Tamsulosin 0,4 mg

Tanzânia association placebo

Intervention Type OTHER

EMS association placebo

Interventions

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Tanzânia association

Tanzânia association capsule

Intervention Type DRUG

Omnic Ocas

Tamsulosin 0,4 mg

Intervention Type DRUG

Omnic Ocas placebo

Tamsulosin placebo

Intervention Type OTHER

Tanzânia association placebo

EMS association placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No