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

Sponsor

EMS (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04185441

Collaborator

(none)

262

Enrollment

Location

Arms

25.6

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Benign Prostatic Hyperplasia	Drug: Tanzânia association Drug: Omnic Ocas Other: Omnic Ocas placebo Other: Tanzânia association placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

262 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 14, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Incidence and severity of adverse events recorded during the study. [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allergisa	Campinas	São Paulo	Brazil

Sponsors and Collaborators

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EMS

ClinicalTrials.gov Identifier:

NCT04185441

Other Study ID Numbers:

EMS0119 - TANZÂNIA

First Posted:

Dec 4, 2019

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by EMS

Erectile Dysfunction

Benign Prostatic Hyperplasia

Additional relevant MeSH terms:

Erectile Dysfunction

Prostatic Hyperplasia

Hyperplasia

Study Results

No Results Posted as of Jul 27, 2022