Pharmacokinetics Clinical Trial
Official title:
Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®
There are over 60 million women of reproductive age in the U.S. and a majority of these
women qualify as overweight or obese. Evidence suggests that there is an association between
increased body weight and decreased contraceptive efficacy. Studies with the combined
hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®)
demonstrate higher failure rates in heavier versus lighter women.
Weight related differences in the effectiveness of NuvaRing® need further study. A single
secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no
difference in pregnancy rates among women in the highest weight decile (>166#) versus the
rest of the study population using the ring. (Westhoff, 2005) The finding of no difference,
however, was influenced by too few obese subjects in the analysis which contributed to wide
confidence limits. Additional studies are needed to explore how well the contraceptive ring
functions to maintain effective serum steroid concentrations to suppress ovarian activity in
obese women.
This investigation focused on evaluating mean serum concentrations of hormones released in
obese and normal weight women using the NuvaRing® . This study was a prospective clinical
trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those
with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined
hormonal contraceptive ring to two months of use to complete analysis of at least 34
subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl
estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression.
These markers included sonographic evidence of follicular development and ovulation as well
as circulating E2 levels which strongly correlate with follicular development and
endometrial proliferation during the second month of NuvaRing® use. Assessment of these
parameters will translated to understanding contraceptive-mediated suppression of ovarian
function in these two groups. Subjects also logged patterns of ring use and bleeding
patterns during the study period.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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