NCT00482209

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,220 (estimated)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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?

Conditions

• Induced Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone, misoprostol	200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
DRUG	mifepristone, misoprostol	200mg mifepristone followed by 800mcg misoprostol 36-48 hours later

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-06-05
• Last updated: 2009-10-12

Locations

4 sites across 2 countries: Georgia, Vietnam