OligospermiaPhase 4NCT06260007
Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia
A Phase 4 study testing Tribulus terrestris in people with Oligospermia, run by Herbarium Laboratorio Botanico Ltda at 1 site in Brazil.
Trial summary
Efficacy and Safety of Products Based on Tribulus terrestris, L. in Men with Oligospermia. It is expected that the benefits of investigational products outweigh the risks that will be mitigated or carefully managed by the study team. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Oligospermia
- What is being tested?
- Tribulus terrestris
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Jul 2024to 17 Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- - Male;
- - Ages 25 and 60;
- - Diagnosis of oligospermia;
- - With sexual partner;
- - Indication of drug treatment with steroid hormones, precursors or analogues.
Who cannot join
- - Severe oligospermia
- - Anatomical change
- - Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues;
- - BMI 35;
- - Participant who presents liver enzyme and creatinine values above the upper limit of normality;
- - History of testicular cancer, or prostate cancer or any other condition that carries risks in this case increased testosterone;
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- - Hypersensitivity to any ingredient present in the formulation;
- - Any criteria or clinical history that, in the investigator's opinion, could compromise the well-being and participant safety;
- - Proven infertility of the partner;
- - History of genetic disorder;
- - History of psychiatric disorder, serious or decompensated illness or any situation that, Investigator's discretion, puts the participant's safety at risk;
- - Active cancer at the discretion of the Investigator;
- - Participants with pregnant and breastfeeding partners;
- - Cycling and horse riding more than 3 hours per week;
- - Alcoholism characterized by the inability to control alcohol consumption according to WHO "drinker excessive, whose dependence on alcohol is accompanied by mental, health and physics, relationships with others and social and economic behavior". Source: https://www.cancer.gov/publications/dictionaries/cancerterms/def/alcoholism;
- - Smoking greater than half a pack per day or equivalent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda
Valinhos, São Paulo, 13271-130
Luciana Bortolassi Ferrara, +551938296160, bdbrasil@azidusbrasil.com.br
About this study
Efficacy and Safety of Products Based on Tribulus terrestris, L. in Men with Oligospermia. It is expected that the benefits of investigational products outweigh the risks that will be mitigated or carefully managed by the study team.
- Conditions
- Oligospermia
- Being tested
- Tribulus terrestris, Placebo
- Medical subject headings
- Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tribulus terrestrisDrug
Tribulus terrestris
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Tribulus terrestris 94mg | Experimental | Not described Receives: Drug: Tribulus terrestris |
| Tribulus terrestris 280mg | Experimental | Not described Receives: Drug: Tribulus terrestris |
| Tribulus terrestris 250mg | Experimental | Not described Receives: Drug: Tribulus terrestris |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo.
Any improvement in sperm concentration (n/mL)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start12 Jul 2024
- Primary completionFeb 2026 (estimated)
- Study completion17 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligospermiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herbarium Laboratorio Botanico Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260007
- Sponsor's protocol ID
- TRIHER0323OR-IV
- Status last verified
- Apr 2025
- First submitted
- 28 Nov 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia
- ClinicalTrials.gov ID
- NCT06260007
- Acronym / sponsor ID
- TRIHER0323OR-IV
- Conditions
- Oligospermia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Herbarium Laboratorio Botanico LtdaIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- 17 Aug 2026 (estimated)
- First posted
- 14 Feb 2024 (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.
Efficacy and Safety of Products Based on Tribulus terrestris, L. in Men with Oligospermia. It is expected that the benefits of investigational products outweigh the risks that will be mitigated or carefully managed by the study team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tribulus terrestris 94mg | Experimental | Drug: Tribulus terrestris |
| Tribulus terrestris 280mg | Experimental | Drug: Tribulus terrestris |
| Tribulus terrestris 250mg | Experimental | Drug: Tribulus terrestris |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - Male;
- - Ages 25 and 60;
- - Diagnosis of oligospermia;
- - With sexual partner;
- - Indication of drug treatment with steroid hormones, precursors or analogues.
Key exclusion criteria (16 listed)
- - Severe oligospermia
- - Anatomical change
- - Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues;
- - BMI 35;
- - Participant who presents liver enzyme and creatinine values above the upper limit of normality;
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 |
|---|---|---|
| Tribulus terrestrisTribulus terrestris | Drug | Tribulus terrestris 250mg, Tribulus terrestris 280mg, Tribulus terrestris 94mg |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo.
Time frame: 3 months
Any improvement in sperm concentration (n/mL)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 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.
Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda
Valinhos, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tribulus terrestris in people with Oligospermia, run by Herbarium Laboratorio Botanico Ltda 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 6 Apr 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo. (time frame: 3 months). 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 6 Apr 2025.