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

Phase 3

• Conditions: Erectile Dysfunction; Benign Prostatic Hyperplasia
• Interventions: Drug: Tanzânia association; Drug: Omnic Ocas; Other: Omnic Ocas placebo; Other: Tanzânia association placebo

• Registration Number: NCT04185441
• Lead Sponsor: EMS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-04
• Study Start: 2021-03-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27
• Primary Completion: 2023-02
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 262

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TANZÂNIA	Tanzânia association	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.
TANZÂNIA	Omnic Ocas placebo	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	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.
Omnic Ocas	Tanzânia association placebo	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence and severity of adverse events recorded during the study.	10 weeks

Trial Locations

Locations (1)

Allergisa; 🇧🇷 Campinas, São Paulo, Brazil