Erectile DysfunctionPhase 3NCT04185441
Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
A Phase 3 study testing Tanzânia association and Omnic Ocas in people with Erectile Dysfunction and Benign Prostatic Hyperplasia, run by EMS at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Benign Prostatic Hyperplasia
- What is being tested?
- Tanzânia association and Omnic Ocas
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Mar 2021to 5 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Erectile Dysfunction, Benign Prostatic Hyperplasia
- Being tested
- Tanzânia association, Omnic Ocas, Omnic Ocas placebo, Tanzânia association placebo
- Keywords
- Erectile Dysfunction, Benign Prostatic Hyperplasia
- Medical subject headings
- Erectile Dysfunction, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tanzânia associationDrug
Tanzânia association capsule
Omnic OcasDrug
Tamsulosin 0,4 mg
Omnic Ocas placeboOther
Tamsulosin placebo
Tanzânia association placeboOther
EMS association placebo
| Study group | Role | What they receive |
|---|---|---|
| TANZÂNIA | Experimental | 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. Receives: Drug: Tanzânia association; Other: Omnic Ocas placebo |
| Omnic Ocas | Active comparator | 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. Receives: Drug: Omnic Ocas; Other: Tanzânia association placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start14 Mar 2021
- Primary completion10 Oct 2023
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185441
- Sponsor's protocol ID
- EMS0119 - TANZÂNIA
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2019
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04185441
- Acronym / sponsor ID
- EMS0119 - TANZÂNIA
- Conditions
- Erectile Dysfunction, Benign Prostatic Hyperplasia
- Keywords
- Erectile Dysfunction, Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TANZÂNIA | Experimental | Drug: Tanzânia association, Other: Omnic Ocas placeboThe 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. |
| Omnic Ocas | Active comparator | Drug: Omnic Ocas, Other: Tanzânia association placeboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tanzânia associationTanzânia association capsule | Drug | TANZÂNIA |
| Omnic OcasTamsulosin 0,4 mg | Drug | Omnic Ocas |
| Omnic Ocas placeboTamsulosin placebo | Other | TANZÂNIA |
| Tanzânia association placeboEMS association placebo | Other | Omnic Ocas |
Primary outcome
Change from baseline in erectile function questionnaire.
Time frame: 8 weeks
The erectile function questionnaire score ranges from 1 to 30 points. The lower the score, the higher the degree of erectile dysfunction.
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tanzânia association and Omnic Ocas in people with Erectile Dysfunction and Benign Prostatic Hyperplasia, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in erectile function questionnaire. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.