Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394999
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-29
Brief Title:
Efficacy Safety and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Prospective Phase III Multi-center Open-label Study of the Efficacy Safety and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
WOMEN
Brief Summary:
Participants in the study will use mifepristone 50 mg once-a-week for one year as a contraceptive With this we want to confirm that the chances of getting pregnant while using this contraceptive are very small We also want to demonstrate that the use of mifepristone is safe and it does not lead to any severe health problems We expect fewer side effects compared to other frequently used contraceptives with hormones Mifepristone does not contain these hormones It is important to know how people experience that use of one tablet a week
Detailed Description:
Mifepristone 50 mg a progesterone receptor modulator is a proven safe emergency contraceptive and a promising new weekly contraceptive As mifepristone does not contain estrogens or progestogens we anticipate users will not experience the undesirable side effects and health risks of current hormonal contraceptives Furthermore pills are a highly desired formulation approach and a weekly regimen instead of daily administration will likely contribute to a high acceptability and adherence among users Based on promising early stage clinical data we expect the use of weekly mifepristone 50 mg as a contraceptive will be safe effective and acceptable
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?:
None
Is an FDA AA801 Violation?:
None