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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185441
• Other study ID #: EMS0119 - TANZÂNIA
• Status: Recruiting
• Phase: Phase 3
• Start date: March 14, 2021
• Est. completion date: May 2023

Study information

• Verified date: July 2022
• Source: EMS
• Contact: Alexandra Dumont Alves, MD
• Phone: +551938877246
• Email: pesquisa.clinica[@]ncfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: May 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Erectile Dysfunction
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Tanzânia association
Tanzânia association capsule
• Omnic Ocas
Tamsulosin 0,4 mg

Other:
• Omnic Ocas placebo
Tamsulosin placebo
• Tanzânia association placebo
EMS association placebo

Locations

Country	Name	City	State
Brazil	Allergisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	Incidence and severity of adverse events recorded during the study.		10 weeks