An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement on Total Testosterone, Sex Drive and Energy Level in Senior Men
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in serum total testosterone concentration compared to baseline
研究概览
简要总结
To evaluate the effect and support the tolerance of orally ingested formulation containing Eurycoma longifolia dietary supplement (Euryco-10) on a cohort of senior men.
详细描述
This is a single-center, single arm, open label study in senior men. This study will investigate the effect and tolerance of oral ingestion of Euryco-10. Subjects meeting all inclusion and none of the exclusion criteria will be enrolled and provided with study dietary supplement. Subjects will be instructed to take 2 capsules per day for 35 days. Administration and any adverse events will be recorded in the subject diary. At each clinic visit (Day 0, Day 21 and Day 35) the Subject will complete the AMS Questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male ≥ 55 years of age
排除标准
- •Severe lower urinary tract symptoms.
- •Current use of any herbal and/or nutritional supplements that can interfere with testosterone.
- •A history of cancer except melanoma skin cancer.
- •Currently receiving treatment with cancer chemotherapy or antiandrogens.
- •Chronic use of systemic glucocorticoids (use within >14 days up to the 3months prior to screening); use of non-testosterone anabolic steroids within12 months prior to screening.
- •History of frequent opioid use >1 time/week during any week within 30 days prior to screening.
- •Have a history of known angina.
- •Have a history of severe liver disease or clinical evidence of hepatic impairment at screening.
- •Untreated severe obstructive sleep apnea.
- •Allergies to any of the ingredients in Euryco-10® or BioPerine.
- •Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results
结局指标
主要结局
Change in serum total testosterone concentration compared to baseline
时间窗: Day 0, Day 21 and Day 35
次要结局
- Change in Q 9 of the AMS Questionnaire(Day 0, Day 21 and Day 35)
- Change in Q17 of the AMS Questionnaire(Day 0, Day 21 and Day 35)