None listed
Conditions
Interventions
Intervention1: FenuSMART: 250mg Two Times per day for 42 days
Intervention2: FenuSMART: 250mg, Single dose per day for 42 days
Control Intervention1: Placebo: 250mg ,Two Times per Day for 42 days
Sponsors
Akay Flavours and Aromatics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Married, sexually active female subjects. 2 Postmenopausal women according Stages of Reproductive Aging Workshop (STRAW) Classification with -no menstrual bleeding for the last 12 months 3 Perimenopausal 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 4 Healthy menstruating women with regular menstrual cycles. 5 Subjects with a BMI 6 Subjects with normal fasting blood glucose level. 7 Subject understands the study procedures and provides signed informed consent to participate in the study. 8 Females 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. 9 Clinical 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.
Exclusion criteria
Exclusion criteria: 1 History 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 2 Patients who had previous treatment with hormonal treatment or fenugreek derived products in the previous 12 months. 3 Androgen therapy within 3 months of recruitment. 4 Chronic 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. 5 Active gall bladder disease, gynaecological or breast surgery in the last 6 months. 6 History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years 7 Subjects with abnormal ECG, biochemical or haematological values 8 Subjects, who are smokers or tobacco user 9 Pregnant and breast feeding female. 10 History of hypersensitivity reactions attributed to a convectional formulation of FenuSMART• or its components or related products. 11 A positive hepatitis screening including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and /or syphilis. 12 Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication. 13 Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids and morphine) 14 History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 15 Active or history (last 6 months) of drug or alcohol abuse. 16 Participated in a clinical study with an investigational drug or biologic within the last 30 days. 17 Any condition that in opinion of the Investigator, does not justify the subjectsâ?? participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Changes in Biochemical, Hormonal and Molecular MarkersTimepoint: Day 0, Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Questionnaire based assessment scoresTimepoint: Day 0,Day14, Day 28, Day 42;Safety assessment and incidence of adverse EventsTimepoint: Day 0, Day 42 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Private Limited
Outcome results
None listed