Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286208
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2006-02-01
Brief Title:
Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Sponsor:
Gynuity Health Projects
Organization:
Gynuity Health Projects
Study Overview
Official Title:
A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Status:
COMPLETED
Status Verified Date:
2014-02
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 open-label randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol ie 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
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
Detailed Description:
None
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