Obesity Clinical Trial
Official title:
Prenatal Growth Programs Oral Contraceptive Metabolism and Effectiveness
Contraceptive failure is the primary cause of unintended pregnancy in the United States. With
obesity rates at epidemic proportions, any association between obesity and strategies that
prevent undesired pregnancies constitutes a significant public health and economic concern.
Evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels
of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral
contraceptive efficacy. Furthermore, preliminary analysis suggested that a sub-group of obese
women, defined by their own birth weight, are at higher risk of contraceptive failure.
Further studies are necessary to investigate whether birth weight, a surrogate marker of in
utero growth restriction, is a useful diagnostic marker for the identification of women prone
to contraceptive failure. Such an understanding is critical to finding a contraceptive
strategy with better efficacy for these women.
The overall goal of this project is to test pharmacokinetics of oral contraceptive agents in
obese women with low birth weight and compare to obese women with normal birth weight. The
main hypothesis for this proposal is that an adverse in utero environment programs the
expression and function of enzymes and transporters that underlie pharmacokinetics of oral
contraceptives, and leads to contraceptive failure.
Reproductive-aged, ovulatory women of obese BMI >30 kg/m2 with normal birth weight (5.5-8
lbs; n=10) and low birth weight (<5.5 lbs; n=10), will be placed on oral contraceptives for 1
month. At several key time points, synthetic steroid pharmacokinetics, gonadotropins
(luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol,
progesterone) will be monitored.
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