A clinical study to evaluate the safety and to understand the efficacy of FenuSMART on sexual functions and menstrual problems in wome
- Registration Number
- CTRI/2018/09/015614
- Lead Sponsor
- Akay Flavours and Aromatics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Changes in Biochemical, Hormonal and Molecular MarkersTimepoint: Day 0, Day 42
- Secondary Outcome Measures
Name Time Method Changes in Questionnaire based assessment scoresTimepoint: Day 0,Day14, Day 28, Day 42;Safety assessment and incidence of adverse EventsTimepoint: Day 0, Day 42