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Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone

NCT00680394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2013-03-13

No results posted yet for this study

Summary

A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days' LMP. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol. We hypthesize that both methods work well, but that the mifepristone regimen will have an efficacy rate of approximately 95%, and misoprostol alone will be closer to 90%. We will consider a greater than 5% difference to be clinically meaningful.

Conditions

  • Pregnancy Termination

Interventions

DRUG

mifepristone

200 mg mifepristone

DRUG

misoprostol

800 buccal misoprostol + matching placebo or 1600 buccal misoprostol

DRUG

placebo

800 buccal misoprostol + matching placebo or 1600 buccal misoprostol

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Tunisia
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs

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 NCT00680394 on ClinicalTrials.gov