CTRI/2025/11/098051尚未招募3 期
A Prospective, Open-Label, Single-Arm, Single-Centre, Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Vigorvolt in Male Subjects with Low Libido and Vitality
Vaidyarathnam Oushadhasala1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Brief SummaryThis study will check how safe and effective Vigorvolt is in improving sexual desire and energy levels in men who have low libido and low vitality. A total of 30 men will take Vigorvolt for about 60 days, and the study will measure changes in testosterone levels, sexual desire, fatigue, and overall energy. Safety will also be monitored through regular check-ups and lab tests.
Purpose of the StudyThe purpose of this study is to see whether Vigorvolt can naturally improve sexual desire, energy, and overall strength in men with low libido and low vitality, and to confirm that it is safe to use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male Participants aged 21 to 55 years at the time of consent.
- •Documented low serum total testosterone (less than or equal to 300 ng/dL), confirmed by a morning (08:00 10:00) sample at Screening.
- •Self-reported symptoms of low libido and vitality, including at least one of the following for greater than or equal to 3 months: o Decreased sexual drive or reduced initiation of sexual activity.
- •o Difficulty in becoming sexually aroused.
- •o Fatigue and low energy levels.
- •Willingness to comply with the study protocol, including scheduled visits, treatment plan, laboratory tests, and other procedures.
- •Able to provide written informed consent prior to initiation of any study-related procedures.
排除标准
- •History of psychiatric illness (e.g., major depression, psychosis) or alcohol dependence.
- •Established or known organic pathology for sexual dysfunction (e.g., severe endocrinopathies, untreated hypogonadism requiring TRT, significant prostatic disease).
- •Body Mass Index (BMI) greater than 37 kg/m² at Screening.
- •Severe lower urinary tract infection and/or clinically significant prostate enlargement (per investigator’s judgment).
- •Current or recent (within 6 months prior to Screening) use of long-acting intramuscular testosterone undecanoate or testosterone pellets.
- •Evidence of renal, hepatic, or cardiac failure.
- •Known HIV infection.
- •Participation in any other interventional clinical trial within the last 3 months.
- •Use of any other investigational drug within 1 month prior to randomization.
研究者
Dr Deepak M
Sri Lakshmi Super Speciality Hospital
研究点 (1)
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