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Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG

NCT02863445 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-06-15

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. The PI's 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. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but this protocol registration is for the LNG aspect of the study procedures.

Conditions

Interventions

DRUG

Levonorgestrel-based emergency contraception 1.5 mg

Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC

DRUG

Levonorgestrel-based emergency contraception 3.0mg

Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-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
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2021-01-16
Completion
2021-08-16
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 NCT02863445 on ClinicalTrials.gov