Oral Contraceptives and Body Mass Index
Oral Contraceptives and Body Mass Index
The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral
 contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
This study is being conducted to understand how effective oral hormonal birth control (the
 pill) is for women with high body mass index ("BMI" - the ratio of your height and weight
 BMI"). Previous studies of birth control traditionally do not include women above a certain
 BMI number, so safety and efficacy is not clearly understood in this population, yet the pill
 is still widely used in women with high BMI.

 Reproductive-aged, ovulatory women of obese (BMI >30 kg/m2), will be placed on oral
 contraceptives for 2 months, then randomized into two intervention arms for an additional 2
 months. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (LH,
 FSH) and ovarian hormone levels (estradiol, progesterone), ovarian follicular activity by
 ultrasound monitoring, and cervical mucus testing will be monitored.
Inclusion Criteria:

 -  Age 18-35

 -  BMI > 30kg/m2

 -  Proof of a normal breast and pelvic exam within last 9 months

 -  Self reported normal menstrual periods (24-35 days)

 -  Good general health

 -  In the investigator's opinion, are subject's veins suitable the repeat blood draws
 dictated by study protocol

 -  Single progesterone level during screening visit ≥ 3ng/mL

 -  Hematocrit ≥ 36%

 Exclusion Criteria:

 -  Contradictions to COCs (history of deep vein thrombosis,myocardial infection,
 uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke,
 migraines with neurologic changes, breast cancer, impaired liver function,
 uncontrolled thyroid disease, hypersensitivity or allergy to birth control)

 -  Smoker (must smoke 0 cigarettes)

 -  Actively seeking/involved in a weight loss program

 -  Currently pregnant/seeking pregnancy in the next 6 months

 -  Currently breast-feeding

 -  Past or current diagnosis of polycystic ovarian disease

 -  Recent use of birth control (Depot medroxyprogesterone: 6 months, Progestin implants:
 6 months, Oral contraceptives, patch or ring: 2 months, Hormone impregnated IUD: 6
 months)

 -  Currently taking medication that interferes with COC's (Rifampin, Carbamazepine, St.
 John's Wort)