The Effects of OCP and Metformin on Clinical, Hormonal, Metabolic and Ultrasonographic Characteristics in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Metformin; ethinyl estradiol and cyproterone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Oral Contraceptive Pill
Intervention MeSH terms: Metformin; Cyproterone Acetate; Ethinyl Estradiol; Estradiol; Cyproterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment