Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431132
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2007-02-02
Brief Title:
Endometrial Safety of a Low Dose of Vagifem in Postmenopausal Women With Atrophic Vaginitis
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A 12 Month Open-label Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose 10ug 17beta-estradiol Vaginal Tablet in Postmenopausal Women With Atrophic Vaginitis Symptoms
Status:
COMPLETED
Status Verified Date:
2017-02
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 trial is conducted in Europe The purpose of this study is to evaluate endometrial safety of intravaginal estradiol Vagifem in healthy postmenopausal women having atropic vaginitis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-001629-24 | EUDRACT_NUMBER | None | None |