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

EMS

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia; Erectile Dysfunction

Treatments: Other: Omnic Ocas placebo; Drug: Omnic Ocas; Other: Tanzânia association placebo; Drug: Tanzânia association

Study type: Interventional

Funder types: Industry

Identifiers

NCT04185441

EMS0119 - TANZÂNIA

Details and patient eligibility

About

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.

Enrollment: 295 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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295 participants in 2 patient groups

TANZÂNIA

Experimental group

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.

Treatment:

Drug: Tanzânia association

Other: Omnic Ocas placebo

Omnic Ocas

Active Comparator group

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.

Treatment:

Other: Tanzânia association placebo

Drug: Omnic Ocas