NCT06260007招募中4 期
Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ages 25 and 60;
- •Diagnosis of oligospermia;
- •With sexual partner;
- •Indication of drug treatment with steroid hormones, precursors or analogues.
排除标准
- •Severe oligospermia
- •Anatomical change
- •Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues;
- •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.
研究组 & 干预措施
Tribulus terrestris 94mg
Experimental
干预措施: Tribulus terrestris (Drug)
Tribulus terrestris 280mg
Experimental
干预措施: Tribulus terrestris (Drug)
Tribulus terrestris 250mg
Experimental
干预措施: Tribulus terrestris (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo.
时间窗: 3 months
Any improvement in sperm concentration (n/mL)
次要结局
未报告次要终点
研究者
研究点 (1)
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