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

Phase 4

Recruiting

• Conditions: Oligospermia
• Interventions: Drug: Tribulus terrestris; Other: Placebo

• Registration Number: NCT06260007
• Lead Sponsor: Herbarium Laboratorio Botanico Ltda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-14
• Study Start: 2024-07-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-02
• Study Completion: 2026-08-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tribulus terrestris 280mg	Tribulus terrestris	-
Tribulus terrestris 250mg	Tribulus terrestris	-
Placebo	Placebo	-
Tribulus terrestris 94mg	Tribulus terrestris	-

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo.	3 months	Any improvement in sperm concentration (n/mL)

Trial Locations

Locations (1)

Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda; 🇧🇷 Valinhos, SP, Brazil