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

Herbarium

Status and phase: Enrolling; Phase 4

Conditions: Oligospermia

Treatments: Drug: Tribulus terrestris; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06260007

TRIHER0323OR-IV

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: Male

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 4 patient groups, including a placebo group

Tribulus terrestris 94mg

Experimental group

Treatment:

Drug: Tribulus terrestris

Tribulus terrestris 280mg

Experimental group

Treatment:

Drug: Tribulus terrestris

Tribulus terrestris 250mg

Experimental group

Treatment:

Drug: Tribulus terrestris

Placebo

Placebo Comparator group

Treatment:

Other: Placebo