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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tribulus terrestris 94mg | Experimental |
| |
| Tribulus terrestris 280mg | Experimental |
| |
| Tribulus terrestris 250mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tribulus terrestris | Drug | Tribulus terrestris |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo. | Any improvement in sperm concentration (n/mL) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azidus Brasil Pesquisa CientÃfica E Desenvolvimento Ltda | Recruiting | Valinhos | São Paulo | 13271-130 | Brazil |
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| ID | Term |
|---|---|
| D009845 | Oligospermia |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000713868 | Tribulus extract |
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| Placebo | Other | Placebo |
|
| D007246 |
| Infertility |
| D052801 | Male Urogenital Diseases |