Comparing the Effects of Oral Contraceptive Pills Versus Metformin

Korábbi kezelés

• Current use of oral contraceptives, depo progestin, or hormonal implants
• Participation in any study of an investigational drug or device or biological agent within 30 days
• Bariatric surgery procedure in the recent past (<12 months)

Más betegség

• Untreated thyroid disease (TSH <0.45 mlU/mL and > 4.5 mlU/mL)
• History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident
• Current history of alcohol abuse (>14drinks/week)
• Poorly controlled hypertension defined as average systolic blood pressure >= 150 mm Hg or average diastolic >=100 mm Hg obtained on three measurements obtained 5 minutes apart. If treated, average systolic blood pressure >=140 mm Hg or average diastolic >=90 mm Hg
• Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma
• Suspected Cushing's syndrome
• Subjects who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.

Laborértékek

• Type 1 or type 2 Diabetes Mellitus (elevated fasting serum glucose >126mg/dL on two occasions, poorly controlled diabetes (HgbA1C>6.5%), currently receiving anti-diabetic agents, or currently receiving metformin for treatment of diabetes
• Liver disease (AST/ALT>2 times normal or a total bilirubin >2.5 mg/dL)
• Renal disease (BUN>30 mg/dL or serum creatinine >1.4 mg/dL)
• Anemia (hemoglobin <10 mg/dL)

Egyéb

• Current pregnancy or desire of pregnancy during course of study
• Currently breastfeeding
• Known 21 hydroxylase deficiency
• Untreated hyperprolactinemia (2 Levels>30 ng/ml at least one week apart)
• TG>200mg/dl
• Use of lipid lowering or weight loss agents (subjects may wash out from weight loss agents)
• Suspected adrenal or ovarian tumor secreting androgens
• Absolute contraindications to the use of hormonal contraceptives or metformin,

• Women ≥ 18 to ≤ 40 years of age (at the time of screening), with hyperandrogenic PCOS.
• Subjects will be diagnosed with PCOS defined by the most recent Rotterdam criteria based on:
  • androgen excess (defined as an elevated serum T level or hirsutism, based on a Ferriman Gallwey score > 8 (note: > 2 for women of Asian descent)
  • AND either:
  • history of chronic anovulation (8 or fewer periods per year)
  • AND/OR
  • polycystic ovaries.
• BMI ≥ 25 kg/m² to ≤ 48 kg/m² obtained at screening visit.
• In good general health.
• Willing to avoid pregnancy for the duration of the study.