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The Extended Gestational Age Medical Abortion Study

NCT00997347 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2012-07-02

No results posted yet for this study

Summary

This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.

Conditions

  • Medical Abortion

Interventions

DRUG

Mifepristone and misoprostol

200 mg oral mifepristone 800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Yael Swica, MD, MPH · Gynuity Health Projects

  • Hillary Bracken, PhD · Gynuity Health Projects

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States
  • Georgia
  • India
  • Tunisia
  • Ukraine

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 NCT00997347 on ClinicalTrials.gov