Body Weight Clinical Trial
Official title:
Improving Contraceptive Effectiveness in Obese Women
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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