Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 p