CTRI/2024/09/074433进行中（未招募）Phase 3 4
A Prospective, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate the Safety and Efficacy of 300 mg and 500 mg Doses of Fenavari on Menopause Symptoms.
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Mean change of menopause symptoms as assessed by MRS
研究概览
简要总结
This is a prospective, double blind, randomized, placebo controlled, three-arms, parallel group study. After the informed consent process,the subject will be evaluated for symptoms, medical history and medications. The subjects fulfilling the study inclusion criteria and who do not meet any exclusion criteria will be eligible for the study. Subjects shall be randomly assigned in 1:1:1 ratio to one of the three treatment groups. Clinical assessments shall include all the measures required for the primary and secondary objectives of the study. The safety assessments shall include monitoring of adverse events (AEs), physical examination, vital signs measurement, Urine Pregnancy Tests (UPT; for females of childbearing potential), hematology and clinical chemistry and urine routine tests.
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
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects with menopause symptoms, defined as a score of greater or equal to 12 to lesser than equal to 32 in the Menopausal Rating Scale (MRS) at screening (includes both peri-menopausal and post-menopausal women)
- •Subjects who experience hot flashes and/or night sweats at least once per day
- •Subjects who experience at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes
- •Subjects with BMI between 18 and 40 kg/m at the time of screening
- •Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period
- •Subjects willing to refrain from taking any medications or preparations for addressing menopause symptoms, stress or anxiety or mood or sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study
- •Subjects willing to refrain from consuming alcohol 24 hours prior to the test days
- •Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to test days
- •Subjects willing to refrain from vigorous physical activity 12 hours prior to test days 10.Subjects willing to provide written consent
- •Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •1.Subjects having hypersensitivity or history of allergy to the study product 2.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection 3.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator 4.Subjects with a psychiatric diagnosis including anxiety or depression 5.Subjects with sleep disturbances and/or are taking sleep aid medication 6.Subjects with history of using hormonal therapy for menopause 7.Subjects with uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening 8.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications 9.Subjects who have excessive habitual caffeine consumption (greater than 300 mg caffeine/day or greater or qual to 3 cups of caffeinated coffee/day) throughout the study period 10.Subjects with a history of drug and /or alcohol abuse at the time of enrolment 11.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
结局指标
主要结局
Mean change of menopause symptoms as assessed by MRS
时间窗: Baseline, Day 14, Day 28, Day 56 and Day 84
次要结局
- Mean change in Anxiety(Baseline, Day 14, Day 28, Day 56 and Day 84)
- Mean change in Mood(Baseline, Day 14, Day 28, Day 56 and Day 84)
- Mean change in Sleep Quality(Baseline, Day 14, Day 28, Day 56 and Day 84)
- Mean change in the following Biomarkers:(- Serum Estradiol)
- Overall Safety(Baseline, Day 14, Day 28, Day 56 and Day 84)
研究者
Dr Vidya V Bhat
Radhakrishna Multispeciality Hospital
研究点 (3)
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