Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Erection Hardness Score (EHS)
研究概览
简要总结
This is a double blind, randomised, placebo-controlled clinical study with a 12-week participation and 3 groups (2 active groups and 1 placebo group) designed to monitor erectile function symptom severity and the effect Testofen may have on improving erectile function, sexual function, and quality of life.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy male adults aged 40-75 years
- •Currently in a sexual relationship
- •Males with reduced erectile function (Score of <25 on IIEF)
- •Able to provide informed consent
- •Agree not to change current diet and exercise program while enrolled in this trial
- •Agree not to undertake another clinical trial while enrolled in this trial
排除标准
- •History of prostate surgery and/or trauma
- •Receiving/prescribed treatment for erectile dysfunction, including oral medications, vacuum devices, constrictive devices, injections, or urethral suppositories
- •Receiving/prescribed treatment to increase/decrease testosterone levels e.g. androgens/anti androgens
- •Receiving/prescribed treatment to increase/decrease nitrate or nitric oxide levels
- •Unstable or serious illness (e.g. serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, hormone production disorders)*
- •All current malignancies (excluding BCC) or chemotherapy and/or radiotherapy treatment for malignancy within the previous 2 years
- •Receiving/prescribed [e.g., Coumadin or Marevan (warfarin), heparin, dalteparin, enoxaparin) or other anticoagulation therapy (e.g., thromboembolectomy or the use of vena cava filters)
- •Active smokers, nicotine use, alcohol, or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in the active or placebo formula
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participants who have participated in any other related clinical study during the past 1 month
- •a Any participant reporting having been told by their doctor that they have an under or over production of hormones (e.g., testosterone).
- •*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
研究组 & 干预措施
Testofen 600mg
Testofen in capsule form - taken as a 600mg dosage (2 capsules) once daily for 12 weeks.
干预措施: Testofen 600mg (Drug)
Testofen 300mg
Testofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
干预措施: Testofen 300mg (Drug)
Placebo comparator
The placebo will consist of maltodextrin and will appear identical to the Testofen capsules. The placebo will be administered as per the active treatment - 2 capsules once daily for 12 weeks.
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Change in Erection Hardness Score (EHS)
时间窗: Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
Participants will be required to assess their erection quality by using the EHS. They will be asked to rate the hardness of their erection on a scale of one to four, with four being the maximal score.
Change in International Index of Erectile Function (IIEF) questionnaire
时间窗: Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
The IIEF is a self-administered questionnaire in which participants will be asked to answer 15 questions relating to erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction. Lower scores indicated higher perceived erectile dysfunction
次要结局
- Change in cardiovascular circulation(Baseline prior to commencement of study product and Week 12)
- Change in height in anthropometry measurements(Baseline prior to commencement of study product and Week 12)
- Change in Derogatis Interview for Sexual Functioning-Self Report (DISF-SR)(Baseline prior to commencement of study product and Week 12)
- Change in cardiovascular health(Baseline prior to commencement of study product and Week 12)
- Change in weight in anthropometry measurements(Baseline prior to commencement of study product and Week 12)
- Change in waist circumference in anthropometry measurements(Baseline prior to commencement of study product and Week 12)
- Change in the Ageing Male Symptom (AMS) Questionnaire(Baseline prior to commencement of study product and Week 12)
- Hormone levels: Testosterone(baseline to week 12)
- Hormone levels: Free Testosterone(baseline to week 12)
- Hormone levels: DHEA-S(baseline to week 12)
- Hormone levels: androstenedione(baseline to week 12)
- Hormone levels: luteinizing hormone (LH)(baseline to week 12)
- Hormone levels: sex hormone binding globulin (SHBG)(baseline to week 12)
- Hormone levels: oestrogen(baseline to week 12)
- Hormone levels: 5-Dihydrotestosterone(baseline to week 12)
- Hormone levels: 5-alpha reductase(baseline to week 12)
- General Safety Markers: Full Blood Count (FBC)(baseline to week 12)
- General Safety Markers: HgbA1c(baseline to week 12)
- General Safety Markers: electrolytes(baseline to week 12)
- General Safety Markers: renal function(baseline to week 12)
- General Safety Markers: liver function(baseline to week 12)
- General Safety Markers: Lipid profile(baseline to week 12)
- General Safety Markers: TSH(baseline to week 12)
- General Safety Markers: Prolactin(baseline to week 12)
- General Safety Markers: PSA - Insulin(baseline to week 12)
- Participant experience(week 12)
- Safety: Undesirable and unwanted events(Baseline to week 12)