Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482209
Status:
COMPLETED
Last Update Posted:
2009-10-12
First Post:
2007-06-04
Brief Title:
Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation
Sponsor:
Gynuity Health Projects
Organization:
Gynuity Health Projects
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None