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

NCT ID: NCT06260007

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2026-08-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tribulus terrestris 94mg

Group Type: EXPERIMENTAL

Tribulus terrestris

Intervention Type: DRUG

Tribulus terrestris

Tribulus terrestris 280mg

Group Type: EXPERIMENTAL

Tribulus terrestris

Intervention Type: DRUG

Tribulus terrestris

Tribulus terrestris 250mg

Group Type: EXPERIMENTAL

Tribulus terrestris

Intervention Type: DRUG

Tribulus terrestris

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Tribulus terrestris

Tribulus terrestris

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Herbarium Laboratorio Botanico Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Luciana Bortolassi Ferrara

Role: primary

bdbrasil@azidusbrasil.com.br

+551938296160

Other Identifiers

TRIHER0323OR-IV

Identifier Type: -

Identifier Source: org_study_id