Status:
COMPLETED
Oral Contraceptives and Body Mass Index
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Body Weight
Contraceptive Usage
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief 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.
Detailed Description
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01170390
Start Date
September 1 2009
End Date
December 1 2011
Last Update
December 31 2015
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239