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
109 weeks
Total Duration
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AI-Summary
What this Trial Is 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.
CONDITIONS
Official 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
- Diagnosis of oligospermia
- Has a sexual partner
- Indication for drug treatment with steroid hormones, precursors, or analogues
You will not qualify if you...
- Severe oligospermia
- Anatomical changes affecting the reproductive system
- Previous or current treatment with steroid, anabolic, 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 cancer, prostate cancer, or other conditions increasing testosterone risk
- Hypersensitivity to any ingredient in the study product
- Any clinical condition that could compromise participant safety as judged by the investigator
- Proven infertility in sexual partner
- History of genetic disorders
- History of serious psychiatric disorders or illnesses that may risk safety
- Active cancer as judged by the investigator
- Partners who are pregnant or breastfeeding
- Cycling or horse riding more than 3 hours per week
- Alcoholism characterized by inability to control alcohol consumption as defined by WHO
- Smoking more than half a pack of cigarettes per day or equivalent
AI-Screening
AI-Powered Screening
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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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