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

NCT06260007 | Recruiting Phase 4

• 1 other identifier: TRIHER0323OR-IV
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oligospermia

Outcome Measures

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)

  3 months

Study Arms (4)

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

Interventions

Tribulus terrestris DRUG

Tribulus terrestris

Tribulus terrestris 250mg; Tribulus terrestris 280mg; Tribulus terrestris 94mg

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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;
• \- 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;

Sponsors & Collaborators

• Herbarium Laboratorio Botanico Ltda: lead

Study Sites (1)

Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda

Valinhos, São Paulo, 13271-130, Brazil

RECRUITING

MeSH Terms

Conditions

Oligospermia

Interventions

Tribulus extract

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: February 14, 2024
• Study Start: July 12, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 17, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)