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Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone-3 Hour Intervals
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.
Details
| Lead sponsor | Gynuity Health Projects |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 441 |
| Start date | 2009-05 |
| Completion | 2010-07 |
Conditions
- Complete Abortion
Interventions
- medical abortion
Primary outcomes
- Number of women with a complete abortion using study drug alone without recourse to surgical intervention — one week from initial treatment
Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens
Countries
Tunisia, Vietnam