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Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

Induced Abortion Clinical Trial

Clinical Trial Summary

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

Clinical Trial Description

The goal of this study is to provide answers to the following four questions:

1. Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?

2. Are the side effects with buccal use tolerable for women?

3. Is buccal administration of misoprostol acceptable to women?

4. When given a choice, do women prefer to take misoprostol at home or in the clinic? ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00482209
Study type Interventional
Source Gynuity Health Projects
Contact
Status Completed
Phase N/A
Start date May 2007
Completion date October 2009
View Details
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