Overview

Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

Status:
Completed

Trial end date:
2008-01-01

Target enrollment:

Participant gender:

Summary

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally. The goal of this study is to provide answers to the following four questions: 1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)? 2. Are the side effects with sublingual use tolerable for women? 3. Is sublingual administration of misoprostol acceptable to women? 4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?

Phase:

N/A

Details

Lead Sponsor:

Gynuity Health Projects

Treatments:

Mifepristone
Misoprostol