Efficacy of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea.

Inclusion Criteria: * Healthy females aged between 25-40 years with a Body Mass Index (BMI) of approximately 25 to 29 kg/m2. * Healthy women with primary dysmenorrhea Grade 2 (measured using Verbal Multi-dimensional scoring system (VMSS)) at least for 1 day in 50 % of menstrual cycles and maximum pain intensity score ≥4 on a 10 cm VAS for at least 3 menstrual cycles before participating in the study. * Subjects with regular menstrual cycles that typically occur between every 21-35 days (menstrual period 3-7 days) in last 6 months. * Subjects with normal pelvic TVS and breast mammogram. * Subjects without any chronic diseases having symptoms such as burning, itching, abnormal vaginal discharge. * Subjects willing to provide their age of menarche and regularity in menstrual cycle. * Subjects without any clinical history of Gynaecological disorders or ovarian pathology, pelvic pathology like pelvic inflammatory disease, tumour and fibroma or without any history of pelvic surgery (screened using pelvic transvaginal sonography (TVS)) * Subjects with normal thyroid profile * Subjects willing not to use any analgesics 24 hrs. prior screening and throughout the study. * Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study. * Normal vital signs, including electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the t…