drugset / Trial / NCT00680394
Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone
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
Publications
- Blum J, Raghavan S, Dabash R, Ngoc Nt, Chelli H, Hajri S, Conkling K, Winikoff B. Comparison of misoprostol-only and combined mifepristone-misoprostol regimens for home-based early medical abortion in Tunisia and Vietnam. Int J Gynaecol Obstet. 2012 Aug;118(2):166-71. doi: 10.1016/j.ijgo.2012.03.039. Epub 2012 Jun 8.
- Ngoc NT, Blum J, Raghavan S, Nga NT, Dabash R, Diop A, Winikoff B. Comparing two early medical abortion regimens: mifepristone+misoprostol vs. misoprostol alone. Contraception. 2011 May;83(5):410-7. doi: 10.1016/j.contraception.2010.09.002. Epub 2010 Oct 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mifepristone | Small molecule | 200 mg | Oral |
| Subject | Misoprostol | Other / unclassified | 800 ug | Other |
Indications
No indication recorded.