The Effects of CL25216 on Vasomotor Symptoms in Women During Perimenopause: a Randomised, Double-blind, Placebo-controlled Study
This study is to evaluate the effects of CL25216 on vasomotor symptoms in women during Perimenopause. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.
• Healthy overweight women (BMI: 25-29 kg/m2) aged between 40 to 55 years with reports of changes in their menstrual cycle for at least 3 months.
• Participants needed to have a total score of greater than 16 on the Greene Climacteric Scale (GCS), have an intact uterus and ovaries.
• Early Perimenopausal Women according The Stages of Reproductive Aging Workshop (STRAW) Classification (-2) irregular periods without skipping menstrual cycles and more than seven days difference in length of consecutive cycles.
• Subjects with serum FSH \>20 U/L on 3-5 days of menstrual cycle.
• Subjects with normal pelvic TVS and breast mammogram.
• Subjects with normal fasting blood glucose level (\<125 mg/dl).
• Subject understands the study procedures and provides signed informed consent to participate in the study.
• Subjects with normal blood thyroid profile.
• 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.
• 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.