ClinicalTrials.gg
RecruitingNCT06260007Updated Apr 6, 2025

Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia

A Phase 4 interventional study of Tribulus terrestris and Placebo in Oligospermia, sponsored by Herbarium Laboratorio Botanico Ltda. Recruiting at 1 site in Brazil. Open to male participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by Herbarium Laboratorio Botanico Ltda · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Oligospermia

Browse trials for

03

In context

Oligospermia

64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.

This study's planned enrollment of 204 is above the median of 65 across 46 interventional studies indexed under Oligospermia.

Browse Oligospermia studies →

Lead sponsor

Herbarium Laboratorio Botanico Ltda is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Male;
    • Ages 25 and 60;
    • Diagnosis of oligospermia;
    • With sexual partner;
    • Indication of drug treatment with hormones, precursors or analogues.

Exclusion criteria

Exclusion Criteria:

    • Severe oligospermia
    • Anatomical change
    • Previous treatment for oligospermia or concomitant treatment with , anabolic, hormonal precursors such as testosterone or analogues;
    • 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;
    • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
204 participants (estimated)

Study arms

  • Experimental
    Tribulus terrestris 94mg

    Drug: Tribulus terrestris

  • Experimental
    Tribulus terrestris 280mg

    Drug: Tribulus terrestris

  • Experimental
    Tribulus terrestris 250mg

    Drug: Tribulus terrestris

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo.

    Any improvement in sperm concentration (n/mL)

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda
    Valinhos, SP 13271-130, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06260007
Lead sponsor
Herbarium Laboratorio Botanico Ltda
Responsible party
Sponsor
First posted
Feb 14, 2024
Start date
Jul 12, 2024
Primary completion
Feb 2026 (estimated)
Completion
Aug 17, 2026 (estimated)
Last update
Apr 6, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Tribulus extract

Start the discussion