The Extended Gestational Age Medical Abortion Study

Phase 4 Completed 1400 enrolled Gynuity Health Projects

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.

Timeline

Start: 2009-07
Primary completion: 2012-02
Completion: 2012-02

Publications

Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mifepristone	Small molecule	200 mg	Oral
Subject	Misoprostol	Other / unclassified	400 ug	Other
Subject	Misoprostol	Other / unclassified	800 ug	Other

Indications

No indication recorded.