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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
34
Columbia University Medical Center
New York, New York, United States
Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration
LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.
Time frame: Up to 24 hours
Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration
UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.
Time frame: Up to 24 hours
Elimination Half-life of Serum LNG
(t1/2) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
Elimination Half-life of Serum UPA
(t1/2) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
Clearance of Serum LNG
(Cl) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
Clearance of Serum UPA
(Cl) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
Maximum Concentration of Serum LNG
(Cmax) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
Maximum Concentration of Serum UPA
(Cmax) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
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Time to Maximum Concentration of Serum LNG
(Tmax) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
Time to Maximum Concentration of Serum UPA
(Tmax) calculated in women with normal and obese BMI
Time frame: Up to 24 hours