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Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

NCT00482209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1220

Last updated 2009-10-12

No results posted yet for this study

Summary

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

Conditions

  • Induced Abortion

Interventions

DRUG

Mifepristone, misoprostol

200mg mifepristone followed by 400mcg misoprostol 36-48 hours later

DRUG

mifepristone, misoprostol

200mg mifepristone followed by 800mcg misoprostol 36-48 hours later

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

  • Erica Chong, MPH · Gynuity Health Projects

  • Tamuna Tsereteli, MD, MSc, PhD · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Georgia
  • 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 NCT00482209 on ClinicalTrials.gov