Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467493
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2007-04-27
Brief Title:
Partial Double-Blind Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers
Sponsor:
Meditrina Pharmaceuticals
Organization:
Meditrina Pharmaceuticals
Study Overview
Official Title:
A Partial Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Anastrozole an Aromatase Inhibitor on Endometrial Thickness in Healthy Premenopausal Women When Dosed at Various Times During the Menstrual Cycle Protocol M-001
Status:
COMPLETED
Status Verified Date:
2009-06
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:
Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer They act by blocking the action of the enzyme aromatase that is necessary for the production of estradiol This class of drugs aromatase inhibitors are very effective in reducing estradiol levels in postmenopausal women and in treating estrogen receptor positive breast cancers This study is examining the effect of a specific inhibitor anastrozole on endometrial thickness in premenopausal women The endometrium is sensitive to estradiol and also has local aromatase which if inhibited may result in reduced endometrial thickness The main hypothesis is that anastrozole can be administered at any time during the menstrual cycle and reduce endometrial thickness compared to placebo
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