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Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg

NCT03537768 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2025-11-20

No results posted yet for this study

Summary

The proposed research study is a Phase IIb, multi-center, single-blind, randomized study of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg to evaluate EC effectiveness in women with weight ≥ 80 kg who present within 72 hours of unprotected intercourse.

Conditions

  • Contraception

Interventions

DRUG

Ulipristal Acetate

UPA Tablet

DRUG

Levonorgestrel

LNG Tablet

DRUG

Levonorgestrel

LNG Tablet (x2)

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Kimberly Myer

    lead OTHER

Principal Investigators

  • Diana Blithe, PhD · NICHD Director

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2022-04-20
Completion
2022-04-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03537768 on ClinicalTrials.gov