Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 5:11 AM
Study NCT ID:
NCT01647360
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment
Sponsor:
Abbott
Organization:
Study Overview
Official Title:
A Post- Marketing, Prospective,Multicenter, Observational Program: Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Dydrogesterone is a retroprogesterone with a molecular structure similar to natural progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.
In this study, women suffering from menorrhagia and who are treated with dydrogesterone will be observed for impact on QoL with the reduction in severity of bleeding.
In this study, women suffering from menorrhagia and who are treated with dydrogesterone will be observed for impact on QoL with the reduction in severity of bleeding.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: