A Phase 4 interventional study of Metformin and ethinyl estradiol and cyproterone acetate in Polycystic Ovary Syndrome, sponsored by S.C.B. Medical College and Hospital. Completed at 1 site in India. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by S.C.B. Medical College and Hospital · Phase 4, Interventional, and Treatment
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorder in women of reproductive age and is a leading cause of infertility due to anovulation. Oral contraceptive pills (OCPs) are considered as first line medical therapy to regularize menses in woman with PCOS. However they may worsen the metabolic profile of patients by elevating insulin resistance which is already deranged in PCOS. As there is higher prevalence of insulin resistance in Indian women with PCOS, insulin sensitisers like metformin may be more beneficial. Hence this study is undertaken to compare the combined effect of metformin and OCPs on the clinical, hormonal, metabolic and ovarian ultrasonographic characteristics in patients with PCOS and to evaluate whether this combination of drugs is more advantageous than OCPs or metformin alone in improving the clinical and metabolic profile.
We aim to enroll about 120 patients fulfilling the Rotterdam diagnostic criteria for PCOS in our study. Patients will have a baseline clinical examination (Body weight, Body mass index, Waist circumference, Hirsutism score), hormonal profile (FSH, LH, fasting Insulin/glucose ratio, DHEAS, testosterone levels), metabolic profile (fasting and 2 hour post prandial plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides level), ultrasound examination (ovarian volume and subcapsular follicle count, stromal echogenicity) and doppler blood flow study (ovarian stromal velocity, Pulsatility index, Resistivity index, Systolic/Diastolic ratio and stromal vascularization index).
Patients will be then randomized using a computer generated randomization program into two groups according to BMI (\<25 and >25). The randomization will be stratified in order to achieve a homogenous distribution of PCOS patients in both arms of the study with respect to age and body mass index. Each group will be further subdivided into three treatment arms. 1st treatment arm will receive OCP containing 35 microgram ethinyl estradiol and 2 mg cyproterone acetate cyclically (21 days regimen) daily; 2nd treatment arm will receive OCP containing 35 microgram ethinyl estradiol and 2 mg cyproterone acetate cyclically (21 days regimen) while the 3rd treatment arm will receive OCP plus metformin 500 mg twice daily for a period of six months. Each patient will be asked to keep a diary of her menstrual periods over the study period. The patients will be followed up at 3 and 6 months of treatment to evaluate the changes in the above mentioned parameters. Analysis of the data will be done through descriptive and perceptive statistical methods by using Statistical Package for the Social Sciences (SPSS) software.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.
This study's enrollment of 101 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →S.C.B. Medical College and Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
OCP containing 35 microgram ethinyl estradiol and 2 milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill. OCP to be taken for 6 months.
Drug: ethinyl estradiol and cyproterone acetate
Metformin 500mg bid in morning and evening after meals to be taken for 6 months.
Drug: Metformin
Oral Contraceptive Pill
Improvement in menstrual cycle pattern
All the participants will be asked to maintain a menstrual calendar and fill a questionnaire before and at the end of study. The questionnaire will include menstrual cycle dates, duration and amount from which improvement of menstrual pattern will be assessed.
Time frame: 6 months
Change in Abdominal Fat as measured by Waist Circumference in centimeter
Time frame: 6 months
Change in weight as measured in kg
Time frame: 6 months
Improvement in hirsutism measured by Modified Ferriman and Gallwey scores
Time frame: 6 months
Improvement in glucose tolerance (measured by of fasting plasma glucose and 2-hour post prandial plasma glucose)
Time frame: 6 months
Change in waist-to-hip ratio
Time frame: 6 months
Change in Body mass index (kg/m2)
Time frame: 6 months
Lipid profile (Cholesterol, LDL, HDL and Triglyceride) improvement
The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured in mg/dl before and after of treatment in both groups.
Time frame: 6 months
Change in blood level of luteinizing hormone [LH] (mIU/ml)
Time frame: 6 months
Change in blood level of follicle stimulating hormone [FSH] (mIU/ml)
Time frame: 6 months
Change in blood level of Testosterone (nmol/L)
Time frame: 6 months
Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)
Time frame: 6 months
Change in Free androgen Index (FAI)
Free Androgen Index or FAI is a ratio used to determine abnormal androgen status. The ratio is the total testosterone level divided by the sex hormone binding globulin (SHBG) level, and then multiplying by 100.
Time frame: 6 months
Change in Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)
Time frame: 6 months
Changes in fasting serum insulin levels (mIU/L)
Time frame: 6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin concentrations. HOMA-IR = (Glucose x Insulin) / 405; Glucose is expressed in mg/dl and Insulin is expressed in mIU/L
Time frame: 6 months
Ovarian Stromal artery Pulsatility index
Time frame: 6 months
Ovarian Stromal artery Resistivity index
Time frame: 6 months
Chang in ovarian Follicle number by Ultrasonography (USG)
Largest cross-sectional plane of the ovary will be evaluated for follicle number
Time frame: 6 months
Change in ovarian Follicle diameter (in mm) by USG
Largest cross-sectional plane of the ovary will be evaluated for follicle diameter
Time frame: 6 months
Change in Ovarian volume (in cc) by USG
Ovarian volume, estimated according to the formula 1/2 (A x B x C), where A is the longitudinal diameter, B the anteroposterior diameter, and C the transverse diameter of the ovary
Time frame: 6 months
Change in Endometrial thickness (in mm)
Time frame: 6 months
Change in ovarian stromal/total area ratio (S/A)
Ovarian area, evaluated by outlining with the caliper the external limits of the ovary in the maximum plane section. Ovarian stromal area, evaluated by outlining with the caliper the peripheral profile of the stroma, identified by a central area slightly hyperechoic with respect to the other ovarian area.
Time frame: 6 months
Plan to share: Yes
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S.C.B. Medical College and Hospital