NCT00286208

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,443 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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?

Conditions

• Induced Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone, misoprostol

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-02-03
• Last updated: 2014-02-19

Locations

9 sites across 3 countries: Moldova, Tunisia, Turkey (Türkiye)