EC PK in Women With Normal and Obese BMI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index

Conditions
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Contraception

Intervention / Treatment
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* Drug: LNG-EC
* Drug: UPA-EC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18-45 years English-speaking BMI 18.5-24.9 kg/m2 or obese BMI 30.0-39.9 kg/m2 Regular menstrual cycles No use of medroxyprogesterone acetate at least 6 months prior to study enrollment, unless resumption of two menstrual cycles No use of levonorgestrel intrauterine system (levonorgestrel-IUS), etonogestrel implant or combined hormonal contraception at least one month prior to the study and resumption of one menstrual cycle Women who are postpartum or post-abortion will be included if they have had at least one menstrual cycle since their last pregnancy 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 Use of HAART therapy for management of HIV infection Concomitant use of CYP3A4 inducers like rifampin, barbiturates, carbamazepine, lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St. John's Wort and topiramate Current participation in any other trial of an investigational medicine or device in the three months leading up to this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal-BMI<br>Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order. | Drug: LNG-EC<br>* FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg<br>* Other names: Next Choice One Dose;Drug: UPA-EC<br>* FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg<br>* Other names: ella;|
| Other: Obese-BMI<br>Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order. | Drug: LNG-EC<br>* FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg<br>* Other names: Next Choice One Dose;Drug: UPA-EC<br>* FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg<br>* Other names: ella;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination Half-life of Serum LNG | (t1/2) calculated in women with normal and obese BMI | Up to 24 hours | 
| Elimination Half-life of Serum UPA | (t1/2) calculated in women with normal and obese BMI | Up to 24 hours | 
| Clearance of Serum LNG | (Cl) calculated in women with normal and obese BMI | Up to 24 hours | 
| Clearance of Serum UPA | (Cl) calculated in women with normal and obese BMI | Up to 24 hours | 
| Maximum Concentration of Serum LNG | (Cmax) calculated in women with normal and obese BMI | Up to 24 hours | 
| Maximum Concentration of Serum UPA | (Cmax) calculated in women with normal and obese BMI | Up to 24 hours | 
| Time to Maximum Concentration of Serum LNG | (Tmax) calculated in women with normal and obese BMI | Up to 24 hours | 
| Time to Maximum Concentration of Serum UPA | (Tmax) calculated in women with normal and obese BMI | Up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency contraception