An Open-Label, Single Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of HSLG-032303 in Healthy Adult Males with Low Libido.
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy Endpoints
研究概览
简要总结
Study Title: An Open-Label, Single Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of HSLG-032303 in Healthy Adult Males with Low Libido.
Protocol Number: HWC/MSCD/PP/009/2024
Version Number: 1.1, Dated: 28th Jun 2024
This is an Interventional clinical study. The study is designed to evaluate safety & efficacy of the investigational product HSLG-032303.
The study will last for 4 weeks per subject, with the aim to screen a sufficient number of subjects to obtain at least 40 evaluable subjects. The study population consists of adult male subjects aged between 21-50 years, as defined by the study’s inclusion/exclusion criteria.
This is a Single Arm Study, meaning all participants receive the same intervention. The study involves 3 visits: a screening visit within 7 days prior to baseline, a baseline visit on Day 1, and an end-of-study visit on Day 28 (with a +2 days window period).
Subjects who meet the eligibility criteria will be enrolled into the study after signing the informed consent. They will be given the investigational product on Day 1 and advised to take it for a period of 28 days.
The study’s efficacy will be measured by the number of subjects showing improvement and/or mean improvement in the Sexual Desire Inventory (SDI) scale and each symptom of the Aging Male Symptoms Scale (AMS) from baseline to the end of the study.
Safety will be assessed through general physical examinations & vital signs, laboratory examinations, and monitoring the incidence of adverse events during the study period. The proportion of subjects withdrawing from the trial due to adverse events will also be noted as a measure of the product’s tolerability.
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 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects aged 21 to 50 years with general good health.
- •2.Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical and laboratory examinations.
- •3.Subjects with Sexual Desire Inventory (SDI) Scale score 45 or lower indicating low sexual desire/ low libido.
- •4.Subjects willing to sign an informed consent document.
- •5.Subjects willing to adhere to protocol requirements throughout the study period.
- •6.Subjects who have not participated in any clinical study in the past 30 days.
排除标准
- •1.Subjects with known clinically significant cardiovascular, neurological, respiratory, gastrointestinal, genitourinary, congenital or any other disorder as determined by the investigator that may interfere with the study outcome or put the subjects in medical risk.
- •2.Subjects with any other sexual disorders like Erectile Dysfunction (ED), Pre-Mature Ejaculation (PME) or subjects taking any other medications like vasodilators, PDE-5 inhibitors, prostaglandins, or any other herbal or dietary supplement for sexual wellness within past one month.
- •3.Subject with any other significant cause of low libido like social, personal, or cultural which in the opinion of the investigator may interfere with the study results.
- •4.Subjects with known history or present condition of allergic response to the study drug or any ingredients in the investigational product.
- •5.Pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications.
- •6.Male subjects who refrain to use adequate contraception and donate sperm from first admission to the study until 90 days after the follow-up visit.
- •7.Known alcohol or any other substance abuse according to DSM-V criteria 8.Any other reason (physical, psychological, or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator.
结局指标
主要结局
Efficacy Endpoints
时间窗: Day 1 And Day 28
•Number of subjects showing improvement and/or improvement in mean Sexual Desire Inventory (SDI) scale score from baseline (day1) to EOS (day28).
时间窗: Day 1 And Day 28
•Number of subjects showing improvement and/or mean improvement in each symptom of Aging Male Symptoms Scale (AMS) score from baseline to EOS.
时间窗: Day 1 And Day 28
次要结局
- Safety Endpoints(•General Physical Examinations & Vital Signs.)
研究者
Dr Praveen B Joshi
Joshis Andrology & Urology Centre