NCT02689804

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2017

Completed
5 months until next milestone

Results Posted

Study results publicly available

July 7, 2017

Completed
Last Updated

July 7, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

February 16, 2016

Results QC Date

February 14, 2017

Last Update Submit

June 30, 2017

Conditions

Contraception

Keywords

Emergency contraception

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Elimination Half-life of Serum LNG

    Up to 24 hours

  • Elimination Half-life of Serum UPA

    Up to 24 hours

  • Clearance of Serum LNG

    Up to 24 hours

  • Clearance of Serum UPA

    Up to 24 hours

  • Maximum Concentration of Serum LNG

    Up to 24 hours

  • +3 more secondary outcomes

Study Arms (2)

Normal-BMI

OTHER

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-ECDrug: UPA-EC

Obese-BMI

OTHER

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-ECDrug: UPA-EC

Interventions

LNG-ECDRUG

FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg

Also known as: Levonorgestrel (LNG) emergency contraceptive (EC), Next Choice One Dose
Normal-BMIObese-BMI
UPA-ECDRUG

FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg

Also known as: Ulipristal acetate (UPA) emergency contraceptive (EC), ella
Normal-BMIObese-BMI

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

  • Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011 Oct;84(4):363-7. doi: 10.1016/j.contraception.2011.02.009. Epub 2011 Apr 2.

    PMID: 21920190BACKGROUND

  • Kapp N, Abitbol JL, Mathe H, Scherrer B, Guillard H, Gainer E, Ulmann A. Effect of body weight and BMI on the efficacy of levonorgestrel emergency contraception. Contraception. 2015 Feb;91(2):97-104. doi: 10.1016/j.contraception.2014.11.001. Epub 2014 Nov 8.

    PMID: 25528415BACKGROUND

  • Gemzell-Danielsson K, Kardos L, von Hertzen H. Impact of bodyweight/body mass index on the effectiveness of emergency contraception with levonorgestrel: a pooled-analysis of three randomized controlled trials. Curr Med Res Opin. 2015 Dec;31(12):2241-8. doi: 10.1185/03007995.2015.1094455. Epub 2015 Oct 27.

    PMID: 26368848BACKGROUND

MeSH Terms

Interventions

LevonorgestrelContraceptives, Postcoitalulipristal acetate

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Results Point of Contact

Title
Carolyn L. Westhoff, MD
Organization
Columbia University
clw3@columbia.edu
212-305-4805

Study Officials

  • Carolyn L Westhoff, MD

    Director, Division of Family Planning and Preventive Services

    PRINCIPAL INVESTIGATOR

  • Piyapa Praditpan, MD

    Clinical instructor, Division of Family Planning and Preventive Services

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Family Planning and Preventive Services

Study Record Dates

First Submitted

February 16, 2016

First Posted

February 24, 2016

Study Start

July 10, 2015

Primary Completion

December 29, 2015

Study Completion

February 3, 2017

Last Updated

July 7, 2017

Results First Posted

July 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Publication Access

Locations

US(1)