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

April 3, 2025 updated by: Herbarium Laboratorio Botanico Ltda
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Valinhos, SP, Brazil, 13271-130
        • Recruiting
        • Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. - Male;
  2. - Ages 25 and 60;
  3. - Diagnosis of oligospermia;
  4. - With sexual partner;
  5. - Indication of drug treatment with steroid hormones, precursors or analogues.

Exclusion Criteria:

  1. - Severe oligospermia
  2. - Anatomical change
  3. - Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues;
  4. - BMI 35;
  5. - Participant who presents liver enzyme and creatinine values above the upper limit of normality;
  6. - History of testicular cancer, or prostate cancer or any other condition that carries risks in this case increased testosterone;
  7. - Hypersensitivity to any ingredient present in the formulation;
  8. - Any criteria or clinical history that, in the investigator's opinion, could compromise the well-being and participant safety;
  9. - Proven infertility of the partner;
  10. - History of genetic disorder;
  11. - History of psychiatric disorder, serious or decompensated illness or any situation that, Investigator's discretion, puts the participant's safety at risk;
  12. - Active cancer at the discretion of the Investigator;
  13. - Participants with pregnant and breastfeeding partners;
  14. - Cycling and horse riding more than 3 hours per week;
  15. - 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;
  16. - Smoking greater than half a pack per day or equivalent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo
Experimental: Tribulus terrestris 94mg
Drug: Tribulus terrestris
Tribulus terrestris
Experimental: Tribulus terrestris 280mg
Drug: Tribulus terrestris
Tribulus terrestris
Experimental: Tribulus terrestris 250mg
Drug: Tribulus terrestris
Tribulus terrestris

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herbarium Laboratorio Botanico Ltda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

August 17, 2026

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIHER0323OR-IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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