drugset / Trial / NCT00680394

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

NCT00680394

Completed 440 enrolled Gynuity Health Projects
RandomizedParallel-groupTriple-blindTreatment

Summary

A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days' LMP. 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. We hypthesize that both methods work well, but that the mifepristone regimen will have an efficacy rate of approximately 95%, and misoprostol alone will be closer to 90%. We will consider a greater than 5% difference to be clinically meaningful.

Timeline

Start
2007-07
Primary completion
2008-05
Completion
2008-05

Drugs

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

Indications

No indication recorded.