Contraception Clinical Trial
Official title:
The Pharmacokinetics of 12 Week Continuous Patch Use
Investigators propose a descriptive pharmacokinetic study of the serum hormone levels of estrogen and progesterone with extended use (12 weeks) of the contraceptive patch. The primary objective is to assess the change in serum Ethinyl Estradiol (EE2) levels over 12 weeks of continuous contraceptive patch use. Additional objectives include assessing the EE2 area under the curve (AUC) during the study time period, as well as Norelgestromin (NGMN) levels and NGMN AUC over the 12 weeks of continuous contraceptive patch use.
For women who are seeking alternatives to long-acting contraceptives, the oral contraceptive
pill and the contraceptive ring are often prescribed in an extended manner (12 weeks
straight). The contraceptive patch, however, is not routinely prescribed in this way.
Concerns have been raised that hormone levels, in particular estrogen, are higher among
patch users than those who use oral contraception or the vaginal ring and that this may
contribute to an increased risk of clot. However, few studies have actually looked at these
hormone levels in women with extended use of the contraceptive patch.
The investigators plan to enroll eligible women age 18-39 who are willing to use the
contraceptive patch continuously for twelve weeks, and can adhere to the study requirements
for follow-up. The investigators will enroll 25 women, in anticipation of a 20% attrition
rate, with the goal of obtaining completed data on 20 participants. The study duration for
an individual participant will be 12 weeks and the duration of the entire study will be one
year.
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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