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

Primary Purpose

Erectile Dysfunction, Benign Prostatic Hyperplasia

Status

Recruiting

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Tanzânia association

Omnic Ocas

Omnic Ocas placebo

Tanzânia association placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Benign Prostatic Hyperplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

AllergisaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TANZÂNIA

Omnic Ocas

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in erectile function questionnaire.

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.

Full Information

NCT ID

NCT04185441

First Posted

December 2, 2019

Last Updated

July 25, 2022

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT04185441

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 14, 2021 (Actual)

Primary Completion Date

February 2023 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction, Benign Prostatic Hyperplasia

Keywords

Erectile Dysfunction, Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

262 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TANZÂNIA

Arm Type

Experimental

Arm Description

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.

Arm Title

Omnic Ocas

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Tanzânia association

Intervention Description

Tanzânia association capsule

Intervention Type

Drug

Intervention Name(s)

Omnic Ocas

Intervention Description

Tamsulosin 0,4 mg

Intervention Type

Other

Intervention Name(s)

Omnic Ocas placebo

Intervention Description

Tamsulosin placebo

Intervention Type

Other

Intervention Name(s)

Tanzânia association placebo

Intervention Description

EMS association placebo

Primary Outcome Measure Information:

Title

Change from baseline in erectile function questionnaire.

Description

The erectile function questionnaire score ranges from 1 to 30 points. The lower the score, the higher the degree of erectile dysfunction.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Incidence and severity of adverse events recorded during the study.

Time Frame

10 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra Dumont Alves, MD

Phone

+551938877246

pesquisa.clinica@ncfarma.com.br

Facility Information:

Facility Name

Allergisa

City

Campinas

State/Province

São Paulo

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabricio Benvenutti, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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