An observational study in Contraception, Fetal Growth Retardation and Infant, Small for Gestational Age, sponsored by Oregon Health and Science University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by Oregon Health and Science University · Observational
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.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's enrollment of 26 is below the median of 161 across 142 observational studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
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Reproductive-aged, ovulatory women seeking to initiate contraception with combined oral contraceptives will be recruited from the female population of the Portland, OR area. Subjects must have access to their birth weight record. Enrollment will be confined to women who have not used a hormonal contraceptive method for 30 days or more prior to enrollment.
Exclusion Criteria:
Measure pharmacokinetic parameters of oral contraceptives including drug clearance.
Serum concentration-time data for each subject will be analyzed using a non-compartmental model assumption. Serum concentrations below the lower limit of quantitation (LLOQ) at the beginning and end of the profile will be set to zero. Serum concentration-time profiles will be summarized using descriptive statistics and graphical display. Student t-tests will be used to test whether the average values of each of the pharmacokinetic parameters, including free concentrations, differ between the four groups of women.
Time frame: on day 21 of oral contraceptive use
Measure levels of gonadotropins and ovarian hormones
To compare gonadotopin levels, average leutinizing hormone and follicle stimulating hormone levels measured for days 21-25 will be calculated. In addition, the follicle stimulating hormone/leutinizing hormone ratio will be calculated at each time point. The average levels of these measures will then be compared between the four groups of women using a student's t-test.
Time frame: Days 21-25 of oral contraceptive use
This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University