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NCT Number: NCT06260007

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

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.

Recruiting

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Key information

Age range

25 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda

Valinhos, São Paulo, 13271-130, Brazil

Location status: Recruiting

Location contact

Luciana Bortolassi Ferrara

CONTACT

[email protected]

+551938296160

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • - Proven infertility of the partner;
  • - History of genetic disorder;
  • - History of psychiatric disorder, serious or decompensated illness or any situation that, Investigator's discretion, puts the participant's safety at risk;
  • - Active cancer at the discretion of the Investigator;
  • - Participants with pregnant and breastfeeding partners;
  • - Cycling and horse riding more than 3 hours per week;
  • - 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;
  • - Smoking greater than half a pack per day or equivalent.

Treatment and study plan

Tribulus Terrestris

Drug

Tribulus terrestris

Placebo

Other

Placebo

Primary outcomes

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

    Time frame: 3 months

    Any improvement in sperm concentration (n/mL)

Sponsors and collaborators

Lead sponsor

Herbarium Laboratorio Botanico Ltda

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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