EC PK in Women With Normal and Obese BMI

Completed · Phase 4

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT02689804

Run by

Columbia University

People needed

34

Starts

2015-07-10

Expected to finish

2017-02-03

Last updated by the study team

2017-07-07

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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