Oral Contraceptives and Body Mass Index

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel; Polyestradiol phosphate

Criteria

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)