RecruitingPhase 4

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

Brazil204 participantsStarted 2024-07-12

Plain-language 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.

Who can participate

Age range25 Years – 60 Years

SexMALE

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Inclusion criteria

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

Exclusion criteria

✕. \- 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;

What they're measuring

Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo.

Timeframe: 3 months

Trial details

NCT IDNCT06260007

SponsorHerbarium Laboratorio Botanico Ltda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02

View on ClinicalTrials.gov More Oligospermia trials