CTRI/2018/09/015614尚未招募不适用
A randomized, double blind, placebo controlled, clinical study to evaluate the safety and efficacy of FenuSMARTâ„¢ on sexual function and menstrual problems in menstruating, perimenopausal and postmenopausal women
Akay Flavours and Aromatics Private Limited1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年6月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- •Changes in Biochemical, Hormonal and Molecular Markers
研究概览
简要总结
This is a randomized , double blind, placebo controlled, parellel group,multicenter study. The main prurpose of this study is to prove the efficacy of FenuSMARTâ„¢ on sexual function and menstrual problems in menstruating,perimenopausal, postmenopausal women. Female subjects meeting all inclusion criteria and no exclusion criteria will sign a written informed consent and will be enrolled in the study.The study consists of seven groups, post-menopausal- treated and placebo, perimenopausal - treated and placebo and regular menstruating women - treated and placebo. The efficacy and safety of FenuSMARTâ„¢ will be established by in comparison with baseline values. The study will also evaluate effect of FenuSMARTâ„¢ on hormonal markers and its effect on safety parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1Married, sexually active female subjects.
- •2Postmenopausal women according Stages of Reproductive Aging Workshop (STRAW) Classification with -no menstrual bleeding for the last 12 months 3Perimenopausal Women according STRAW Classification.
- •Late perimenopause amenorrhoea for ≥60 days.
- •Early perimenopause -irregular periods without skipping cycles and more than seven days difference in length of consecutive cycles 4Healthy menstruating women with regular menstrual cycles.
- •5Subjects with a BMI ≤ 35 kg/m2 6Subjects with normal fasting blood glucose level.
- •7Subject understands the study procedures and provides signed informed consent to participate in the study.
- •9Clinical screening including vital signs, electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
排除标准
- •1History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs on a daily basis for any conditions 2Patients who had previous treatment with hormonal treatment or fenugreek derived products in the previous 12 months.
- •3Androgen therapy within 3 months of recruitment.
- •4Chronic or acute life stressors relating to a major life change, experiencing depression and/or receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone levels.
- •5Active gall bladder disease, gynaecological or breast surgery in the last 6 months.
- •6History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years 7Subjects with abnormal ECG, biochemical or haematological values 8Subjects, who are smokers or tobacco user 9Pregnant and breast feeding female.
- •10History of hypersensitivity reactions attributed to a convectional formulation of FenuSMARTâ„¢ or its components or related products.
- •11A positive hepatitis screening including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and /or syphilis.
- •12Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication.
- •13Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids and morphine) 14History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •15Active or history (last 6 months) of drug or alcohol abuse.
- •16Participated in a clinical study with an investigational drug or biologic within the last 30 days.
结局指标
主要结局
•Changes in Biochemical, Hormonal and Molecular Markers
时间窗: Day 0, Day 42
次要结局
- Changes in Questionnaire based assessment scores(Day 0,Day14, Day 28, Day 42)
- Safety assessment and incidence of adverse Events(Day 0, Day 42)
研究者
研究点 (1)
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