CTRI/2018/09/015614尚未招募未知
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 Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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. Both early and late perimenopause stages. 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.
- •8Females of childbearing potential who are sexually active must agree to use adequate contraception and can neither be pregnant nor lactating from screening throughout the duration of 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 FenuSMART• 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.
- •17Any condition that in opinion of the Investigator, does not justify the subjectsâ?? participation in the study
研究者
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