drugset / Trial / NCT01173003

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

NCT01173003

NaSingle-groupOpen-labelHealth-services research

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?

Timeline

Start
2009-06
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Mifepristone Small molecule 200 mg
Subject Misoprostol Other / unclassified 400 ug Other

Indications

No indication recorded.