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

Oligospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06260007
• Other study ID #: TRIHER0323OR-IV
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 15, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: Herbarium Laboratorio Botanico Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: December 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oligospermia

Intervention

Drug:
• Tribulus terrestris
Tribulus terrestris

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Herbarium Laboratorio Botanico Ltda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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