NCT01173003

Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia

An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 688 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions. The goal of this study is to provide answers to the following four questions: 1. What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual 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. Are women satisfied with counseling and services received in new centers offering medical abortion?

Conditions

• Induced Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone, misoprostol

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-07-30
• Last updated: 2014-02-19

Locations

1 site across 1 country: Tunisia