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

ConditionOligospermia

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexMale

Age25-60

SponsorHerbarium Laboratorio Botanico Ltda

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Male;

- Ages 25 and 60;

- Diagnosis of oligospermia;

- With sexual partner;

Disqualifiers

- Severe oligospermia

- Anatomical change

- Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues;

- BMI 35;

Trial design

Design model

Parallel

Treatments tested in this trial

Tribulus terrestris
Drug
Tribulus terrestris
Placebo
Other intervention
Placebo

Treatment groups

204 Participants

are divided into 4 treatment groups

Group A: Tribulus terrestris 94mgExperimental treatment 1 intervention

Group B: Tribulus terrestris 280mgExperimental treatment 1 intervention

Group C: Tribulus terrestris 250mgExperimental treatment 1 intervention

Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Any improvement in sperm concentration (n/mL)

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Herbarium Laboratorio Botanico Ltda

Lead sponsor

Source ClinicalTrials.gov

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