Oral Contraceptives and Body Mass Index

Completed · Phase 4

Conditions studied: Body Weight, Contraceptive Usage

In brief

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.

Key facts

Study ID

NCT01170390

Run by

Oregon Health and Science University

People needed

32

Starts

2009-09-01

Expected to finish

2011-12-01

Last updated by the study team

2015-12-31

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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)

Where it is running

• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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