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A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The investigators propose a study to compare serum LNG and UPA levels after administration of a single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no difference in PK parameters between women with normal BMI and obese women.
Full description
Eligible women will present to the division research office, at which time a history and physical exam will be completed. Each participant's BMI will be confirmed and she will be assigned to one of two BMI groups (18.5-24.9 versus 30-39.9). At the conclusion of the enrollment visit, the research coordinator will randomize each woman to receive a single-dose pill of either levonorgestrel 1.5mg (like Plan B One-Step® or its generic formulations) or ulipristal acetate 30mg (ellaOne®) on two separate occasions.
Enrollment
Sex
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Inclusion criteria
Exclusion criteria
Prior allergic reaction to LNG-EC or UPA-EC
Use of hormonal emergency contraception within the past month
Women who are currently pregnant or who are currently breastfeeding
History of cancer other than non-melanoma skin cancer
Medical or surgical conditions or conditions requiring therapies known to impact sex steroid production or metabolism
Current participation in any other trial of an investigational medicine or device in the three months leading up to this study
Primary purpose
Allocation
Interventional model
Masking
34 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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