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EC PK in Women With Normal and Obese BMI

NCT02689804 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-07-07

Study results available
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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.

Conditions

  • Contraception

Interventions

DRUG

LNG-EC

FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg

DRUG

UPA-EC

FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg

Sponsors & Collaborators

Principal Investigators

  • Carolyn L Westhoff, MD · Director, Division of Family Planning and Preventive Services

  • Piyapa Praditpan, MD · Clinical instructor, Division of Family Planning and Preventive Services

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-10
Primary Completion
2015-12-29
Completion
2017-02-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02689804 on ClinicalTrials.gov