Columbia University Medical Center
New York, 10032, United States
NCT Number: NCT02689804
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.
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Notify Me18 year–45 year
Female
Interventional
Phase 4
New York, 10032, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg
Other names: Levonorgestrel (LNG) emergency contraceptive (EC), Next Choice One Dose
FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg
Other names: Ulipristal acetate (UPA) emergency contraceptive (EC), ella
Time frame: Up to 24 hours
LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.
Time frame: Up to 24 hours
UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.
Time frame: Up to 24 hours
(t1/2) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
(t1/2) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
(Cl) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
(Cl) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
(Cmax) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
(Cmax) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
(Tmax) calculated in women with normal and obese BMI
Time frame: Up to 24 hours
(Tmax) calculated in women with normal and obese BMI
Columbia University
Other
Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index
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