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

  • STATUS
    Recruiting
  • days left to enroll
    19
  • participants needed
    262
  • sponsor
    EMS
Updated on 5 December 2021
tamsulosin
benign prostatic hyperplasia
hyperplasia
sham treatment

Summary

The purpose of this study is to evaluate the efficacy and safety of Tanznia association in adults with erectile dysfunction associated with Benign Prostatic Hyperplasia.

Details
Condition benign prostatic hyperplasia, Erectile Dysfunction, Benign Prostatic Hyperplasia (Enlarged Prostate), Prostatic disorder, Benign prostatic hypertrophy, Impotence, Prostate Disorders
Treatment Tanzânia association, Omnic Ocas, Omnic Ocas placebo, Tanzânia association placebo
Clinical Study IdentifierNCT04185441
SponsorEMS
Last Modified on5 December 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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