Efficacy and safety of Testosurge capsules for hormonal balance including total testosterone level increase (LC-MS method) in healthy, adult males: A randomized, double-blind, placebo-controlled, crossover, confirmatory study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Testosurge capsules on TT (ng/dL) levels by LC-MS
研究概览
简要总结
Title: Efficacy and safety of Testosurge capsules for hormonal balance including total testosterone level increase (LC-MS method) in healthy, adult males: A randomized, double-blind, placebo-controlled, crossover, confirmatory study.
Study Code: Testosurge-Subacute-Male
Protocol No.: 403-23
Version and Date: Version 1.0, August 16, 2024
Sponsor: Indus Biotech Limited, Pune, India
Investigational Products:
Active: Testosurge 500 mg capsules
PlaceboMatching placebo 500 mg capsules
Design: Randomized, double-blind, placebo-controlled, two-period crossover study.
Objective:
Primary: Assess hormonal balance through total testosterone (TT) levels.
Secondary: Evaluate serum sex hormone-binding globulin (SHBG), calculated free testosterone (cFT), bioavailable testosterone (BT), dihydrotestosterone (DHT), estradiol levels, and metabolic parameters.
Rationale:
In a previous clinical study on Testosurge in sedentary young males (Mokashi, Singh-Mokashi et al. 2014), Testosurge capsules at a single dose of 600 mg showed a significant increase in serum measured free testosterone (mFT), calculated free testosterone (cFT), bioavailable testosterone (BT), and total testosterone (TT), were well tolerated and showed an excellent safety profile, with no adverse events during the study.
Testosurge 500 mg, once a day has been reported to improve male hormonal profiles (serum TT and BT levels) in resistance-trained men with excellent safety profile for 8 weeks (Wilborn, Taylor et al. 2010).
Duration: Total of 30 days, with two 7-day periods separated by a 15-day washout.
Sample Size: 46 healthy adult males aged 18-45.
Eligibility Criteria:
Inclusion: Healthy males within specified age and weight ranges, able to provide informed consent.
Exclusion: Significant medical history, recent drug use, alcohol or caffeine consumption prior to study, and other specific conditions.
Study Site: BioRadius Therapeutic Research Pvt. Ltd., Pune, India.
Key Outcomes:
Primary Efficacy: Measurement of TT levels at specified time points.
Safety Outcomes: Monitoring vital signs and laboratory parameters pre- and post-study.
Statistical Analysis: Descriptive statistics for baseline characteristics and comparisons of efficacy and safety outcomes across treatment groups.
Ethics and Monitoring: The study will adhere to international guidelines and regulatory requirements, with ethics committee approval and ongoing sponsor monitoring to ensure data integrity. This study seeks to further validate the efficacy of Testosurge in promoting hormonal balance in a controlled, scientifically rigorous setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy adult male volunteers aged 18 to 45 years (inclusive) with a weight of at least 50 kg and a Body Mass Index (BMI) between 18.50 and 30.00 kg/m² (inclusive).
- •Volunteers must provide adequate evidence of their identity and demonstrate the capability and willingness to give informed written consent and adhere to study requirements.
- •Participants must be assessed as healthy based on personal and medical history, general medical examination, and absence of significant disease as judged by the Principal Investigator (PI).
- •Volunteers must have normal laboratory parameters (hematology, biochemistry, and serology) or have abnormalities deemed clinically insignificant, with tests conducted within 21 days prior to check-in for Period 1, as judged by the PI.
- •Participants must test negative on a urine screen for drugs of abuse, including cannabinoids (CANNAB/Tetrahydrocannabinol-THC), amphetamines (AMP), barbiturates (BAR), cocaine (COC), benzodiazepines (BZO), and opioids (MOR/OPI).
- •A negative breath alcohol test is required.
- •Volunteers must be willing to use highly effective contraception consistently and correctly throughout the duration of the study.
排除标准
- •History or presence of significant hematopoietic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological conditions, urinary retention, severe gastrointestinal disorders, dysphasia, myasthenia gravis, narrow-angle glaucoma, tachyarrhythmia, psychiatric diseases or disorders, diabetes mellitus, tuberculosis, systemic hypertension, or any medical disorder deemed significant by the Principal Investigator (PI).
- •History of any major surgical procedure, depot injections or drug implants in the past 3 months, or a history of dialysis.
- •History or presence of any medication for joint pain, inflammation, or kidney/urinary tract stones.
- •Recent history of dehydration due to diarrhea, vomiting, or any other cause within 24 hours prior to check-in.
- •History or presence of cancer.
- •Difficulty in donating blood, personal or family history of muscular disorders, or any deformity affecting venous access for cannulation.
- •Consumption of alcohol within 48 hours prior to check-in Day 01 or difficulty abstaining from alcohol during the study.
- •Consumption of caffeine and/or xanthine products (e.g., coffee, tea, chocolate, caffeine-containing sodas) within 24 hours prior to check-in Day 01 for each period.
- •Present or past use of medications that potentially modify the kinetics/dynamics of the study medications, or any other medication deemed clinically significant by the PI.
- •Positive screening test result for any of the following: HIV, Hepatitis B, Hepatitis C, or VDRL.
- •Intake of over-the-counter products, herbal medications, etc., within 7 days prior to check-in Day 01 for each period.
- •Following an unusual diet (e.g., low sodium) for three weeks prior to check-in.
- •History of hypersensitivity to study medications or related excipients in the formulation.
- •History or presence of male sexual dysfunction and use of any medication within the last 30 days that may affect male sex hormones.
- •Intake of supplements containing fenugreek.
- •Intake of any natural or synthetic testosterone-boosting supplements.
- •Any condition that, in the PI’s opinion, makes the subject unsuitable for inclusion.
结局指标
主要结局
To evaluate the efficacy of Testosurge capsules on TT (ng/dL) levels by LC-MS
时间窗: 00.00 h (8:00 pm), 03.00 h (11:00 pm), 07.00 h (3:00 am), 10.00 h (6:00 am), 12.00 h (8:00 am), 15.00 h (11:00 am), 19.00 h (03:00 pm) and 22.00 h (06:00 pm) hours (± 15 minutes) after administration of IP on Day 01 and Day 07 in each period
次要结局
- To evaluate the efficacy of Testosurge capsules on serum SHBG (nmol/L) by Enzyme-linked immunosorbent assay (ELISA)(00.00 h (8:00 pm), 03.00 h (11:00 pm), 07.00 h (3:00 am), 10.00 h (6:00 am), 12.00 h (8:00 am), 15.00 h (11:00 am), 19.00 h (03:00 pm) and 22.00 h (06:00 pm) hours (± 15 minutes) after administration of IP on Day 01 and Day 07 in each period)
- To evaluate the efficacy of Testosurge capsules on the(following parameters-)
研究者
Dr Shailender Singh Tanwar
BioRadius Therapeutic Research Pvt. Ltd.