Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause

Exclusion Criteria19

• 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 daily for any conditions.
• Subjects who had received hormonal treatment or any other herbal products in the previous 6 months.
• Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
• Subjects diagnosed with ovarian cysts ≥ 4 cm or any underlying pathology in pelvic ultrasonography (USG) performed during screening.
• 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.
• Subjects having active gall bladder disease, gynaecological or breast surgery in the last 6 months.
• History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
• Subjects with abnormal ECG.
• Pregnant and breast feeding female.
• History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
• Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication.
• Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids, and morphine).
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
• Participated in a clinical study with an investigational drug or biologic within the last 30 days.
• Any condition that in opinion of the investigator, does not justify the subjects" participation in the study.
• Subjects with a high blood pressure at screening (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• Subjects with progressive systemic diseases (e.g. tuberculosis, leucosis, collagenosis, multiple sclerosis, AIDS, HIV infections, Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or other auto-immune diseases).
• Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
• High alcohol intake (>2 standard drinks per day), smokers (>5 cigarettes per day).