Actively Recruiting
Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia
Led by Herbarium Laboratorio Botanico Ltda · Updated on 2025-04-06
204
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of products based on Tribulus terrestris, L. in men diagnosed with oligospermia, a condition characterized by low sperm count. The study focuses on men between 25 and 60 years old who have a sexual partner and an indication for drug treatment involving steroid hormones or related compounds. The trial is a phase 4, randomized, double-blind study comparing different doses of Tribulus terrestris with a placebo. Participants will be randomly assigned to receive one of several study groups: Tribulus terrestris at doses of 94 mg, 250 mg, or 280 mg, or a placebo. The treatment period lasts for 3 months, during which participants will take the assigned product as directed. The study is designed to carefully manage any risks while assessing how the products affect sperm quality compared to placebo. During the study, men will undergo evaluations of their spermogram to measure changes in sperm characteristics. Researchers will monitor safety through clinical assessments and laboratory tests, including liver enzyme and creatinine levels. The primary outcome is the effectiveness of each product in improving sperm parameters over the 3-month period. Participants' health and well-being will be closely followed throughout the study.
CONDITIONS
Brief Title
Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male
- Ages 25 to 60 years
- Diagnosed with oligospermia
- Has a sexual partner
- Indicated for drug treatment with steroid hormones, precursors, or analogues
You will not qualify if you...
- Severe oligospermia
- Anatomical changes affecting reproductive system
- Previous or current treatment with steroids, anabolic agents, hormonal precursors such as testosterone or analogues
- Body mass index of 35 or higher
- Elevated liver enzymes or creatinine above normal limits
- History of testicular, prostate, or other cancers increasing testosterone-related risks
- Hypersensitivity to any formulation ingredient
- Any clinical condition that may compromise participant safety as judged by the investigator
- Proven infertility of the partner
- History of genetic disorders
- History of serious psychiatric disorders or conditions that may risk safety
- Active cancer as determined by the investigator
- Partners who are pregnant or breastfeeding
- Engages in cycling or horse riding more than 3 hours per week
- Alcoholism characterized by inability to control consumption per WHO definition
- Smoking more than half a pack of cigarettes per day or equivalent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive assigned doses of Tribulus terrestris or placebo to evaluate effectiveness on sperm parameters.
Monthly visits during treatment
Trial Site Locations
Total: 1 location
1
Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13271-130
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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