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Completed

NCT Number: NCT02689804

EC PK in Women With Normal and Obese BMI

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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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LNG-EC

Drug

FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg

Other names: Levonorgestrel (LNG) emergency contraceptive (EC), Next Choice One Dose

UPA-EC

Drug

FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg

Other names: Ulipristal acetate (UPA) emergency contraceptive (EC), ella

Primary outcomes

  1. Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration

    Time frame: Up to 24 hours

    LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.

  2. Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration

    Time frame: Up to 24 hours

    UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.

Secondary outcomes

  1. Elimination Half-life of Serum LNG

    Time frame: Up to 24 hours

    (t1/2) calculated in women with normal and obese BMI

  2. Elimination Half-life of Serum UPA

    Time frame: Up to 24 hours

    (t1/2) calculated in women with normal and obese BMI

  3. Clearance of Serum LNG

    Time frame: Up to 24 hours

    (Cl) calculated in women with normal and obese BMI

  4. Clearance of Serum UPA

    Time frame: Up to 24 hours

    (Cl) calculated in women with normal and obese BMI

  5. Maximum Concentration of Serum LNG

    Time frame: Up to 24 hours

    (Cmax) calculated in women with normal and obese BMI

  6. Maximum Concentration of Serum UPA

    Time frame: Up to 24 hours

    (Cmax) calculated in women with normal and obese BMI

  7. Time to Maximum Concentration of Serum LNG

    Time frame: Up to 24 hours

    (Tmax) calculated in women with normal and obese BMI

  8. Time to Maximum Concentration of Serum UPA

    Time frame: Up to 24 hours

    (Tmax) calculated in women with normal and obese BMI

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Feb 24, 2016
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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