drugset / Trial / NCT01387256

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

NCT01387256

Phase 4 Completed 441 enrolled Gynuity Health Projects
RandomizedParallel-groupTriple-blindTreatment

Summary

This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. 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 three hours apart. All drugs are administered AT home by the participant.

Timeline

Start
2009-05
Primary completion
2010-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Mifepristone Small molecule 200 mg Oral
Subject Misoprostol Other / unclassified 800 ug Other

Indications

No indication recorded.