EC PK in Women With Normal and Obese BMI

• Status: Completed
• Trial end date: 2017-02-03
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Columbia University
• Treatments: Contraceptive Agents; Contraceptives, Postcoital; Levonorgestrel; Ulipristal acetate

Criteria

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