Polycystic ovary disease PCOS Polycystic ovary syndrome Metformin Menstrual irregularity
Conditions
Interventions
metformin 850 mg 1 tab per oral after breakfast
ethinyl estradiol 0.03 mg plus levonorgestrel 0.15 mg 1 tab per oral at the same time of each day,placebo1 tab per oral after breakfast
ethinyl estradio
Active Comparator Drug,Placebo Comparator Drug
metformin and oral contraceptive pill,placebo and oral contraceptive pill
Sponsors
Sunpasitthiprasong hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female patients who have been diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam 2003 diagnostic criteria, which require at least 2 out of the following 3 features: - Irregular menstrual cycles - Clinical and/or biochemical evidence of hyperandrogenism - Polycystic ovaries on ultrasound examination 2. Willingness to participate in the research study
Exclusion criteria
Exclusion criteria: 1. Allergy to metformin 2. Allergy to medications containing ethinyl estradiol or levonorgestrel 3. Pregnant or breastfeeding, or planning to become pregnant during the study 4. History of venous thromboembolism, ischemic or hemorrhagic stroke, ischemic heart disease, or uncontrolled hypertension 5. History of or current breast cancer 6. Patients with diabetes mellitus 7. Impaired kidney function (eGFR <60 ml/min/1.73m2) 8. Impaired liver function (ALT or AST more than 2 times the normal upper limit) 9. Use of metformin, combined oral contraceptives, weight-loss medications, antidiabetic drugs, anti-androgens, or ovulation induction drugs within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to menstruation after medications discontinuation 14 weeks after medications discontinuation menstruation record | — |
Secondary
| Measure | Time frame |
|---|---|
| changes of HDL/TG ratio, HbA1c, and fasting blood sugar before medication and 14 weeks after medications discontinuation laboratory collect and record,change of lipid profile before medication and 14 weeks after medications discontinuation laboratory collect and record,changes of body mass index, body fat mass, waist to hip ratio, and abdominal fat mass before medication and 14 weeks after medications discontinuation Body Composition Analyzer | — |
Countries
Thailand
Contacts
Public ContactPreechaya Prasitpuripreecha
Sunpasitthiprasong hospital
Outcome results
None listed