Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492889
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens
Sponsor:
Gynuity Health Projects
Organization:
Gynuity Health Projects
Study Overview
Official Title:
Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period The first regimen consists of one dose of 15 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone The second regimen will consist of one dose of a placebo pill followed one to two days later by one dose of 200 mg mifepristone
The investigators will assess and compare the efficacy of both regimens proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment and the effectiveness of both regimens proportion of all participants not pregnant at follow-up among all participants enrolled
The investigators will assess and compare the efficacy of both regimens proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment and the effectiveness of both regimens proportion of all participants not pregnant at follow-up among all participants enrolled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None