Polycystic Ovary Syndrome (PCOS) PCOS Combined Oral Contraceptives Estetrol Testosterone
Conditions
Interventions
Participants in the intervention group receive E4/DRSP (15 mg/3 mg) daily for 3 months. ,Participants in the control group receive EE/DRSP (20 mcg/3 mg) daily for 3 months.
Active Comparator Drug,Active Comparator Drug
Estetrol/Drospirenone,Ethinyl Estradiol/Drospirenone
Sponsors
Faculty of Medicine, Khon Kaen University
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Women aged 18-40 years 2.Newly diagnosed with Polycystic Ovary Syndrome (PCOS), meeting at least two out of three criteria according to the International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome 2023, with either clinical hyperandrogenism (hirsutism, acne, alopecia) and/or biochemical hyperandrogenemia 3.Body Mass Index (BMI) ranging from 18 to 30 kg/m2 4.Understand the treatment protocol and be willing to use the assigned oral contraceptive pill (OCP) for the entire study duration 5.Able to read Thai
Exclusion criteria
Exclusion criteria: 1.History of cardiovascular disease, renal disease, adrenal disorders, liver disease, breast disease, thyroid disease, or major psychiatric disorders 2.History of diabetes mellitus or other metabolic disorders, or use of medications/supplements affecting lipid or glucose metabolism 3.Use of steroids, hormonal therapy, or hormonal contraceptives within the past 3 months 4.History of venous thromboembolism (VTE) or pulmonary embolism (PE) 5.History of major surgery within the past 6 months 6.Known allergy to the study medications 7.Immobility or any condition limiting movement 8.Autoimmune diseases, such as Systemic Lupus Erythematosus (SLE) or Antiphospholipid Syndrome (APS) 9.Family history of venous thrombosis, PE, or known thrombophilia 10.Previous treatment for PCOS 11.Current smoker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Free testosterone at 3 months after the end of the intervention Change in Calculated free testosterone from baseline to 3 months, using the Vermeulen et. Al (1999) equation | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile (Cholesterol, HDL, LDL,Triglyceride) at 3 months after the end of the intervention Change in Fasting blood test (mg/dL) from baseline to 3 months,75 gm OGTT (oral glucose tolerance test) at 3 months after the end of the intervention Change in Fasting plasma glucose (FPG) and 2-hour post-load plasma glucose (mg/dL) from baseline to 3 months,Hirsutism at 3 months after the end of the intervention Change in Modified Ferriman-Gallwey score from baseline to 3 months,Acne severity at 3 months after the end of the intervention Change in Investigator's Global Assessment (IGA) Severity Scale from baseline to 3 months,Quality of life at 3 months after the end of the intervention Change in Polycystic Ovary Syndrome-Specific Quality of Life (PCOS-QoL) score from baseline to 3 months | — |
Countries
Thailand
Contacts
Public ContactNatvadee Maleeratana
Faculty of Medicine, Khon Kaen University
Outcome results
None listed