Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation

NCT02314754 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 719

Last updated 2016-07-14

No results posted yet for this study

Summary

To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.

Conditions

  • Medical Abortion

Interventions

DRUG

Mifepristone followed by misoprostol 24-48 hours later

200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD,MPH · Gynuity Health Projects

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States
  • Azerbaijan
  • Georgia
  • Mexico
  • Vietnam

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 NCT02314754 on ClinicalTrials.gov