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Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA

NCT02859337 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-02-06

Study results available
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Summary

Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.

Conditions

Interventions

DRUG

UPA-ECx1

Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC

DRUG

UPA-ECx2

Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • ALISON EDELMAN, MD, MPH · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2022-01-13
Completion
2023-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02859337 on ClinicalTrials.gov