Induced Abortion Clinical Trial
Official title:
A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg
of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration
of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with
misoprostol taken orally.
The goal of this study is to provide answers to the following four questions:
1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at
least as effective as using oral misoprostol up to 63 days since the last menstrual
period (LMP)?
2. Are the side effects with sublingual use tolerable for women?
3. Is sublingual administration of misoprostol acceptable to women?
4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety
(side-effects) or acceptability?
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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