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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Erectile Dysfunction, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Tanzânia association
* Drug: Omnic Ocas
* Other: Omnic Ocas placebo
* Other: Tanzânia association placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TANZÂNIA<br>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<br>* Tanzânia association capsule<br>Other: Omnic Ocas placebo<br>* Tamsulosin placebo<br>|
| Active Comparator: Omnic Ocas<br>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<br>* Tamsulosin 0,4 mg<br>Other: Tanzânia association placebo<br>* EMS association placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study. |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, Benign Prostatic Hyperplasia