Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272714
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2006-01-05
Brief Title:
Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women
Sponsor:
ASCEND Therapeutics
Organization:
ASCEND Therapeutics
Study Overview
Official Title:
A Phase II Randomized Double-Blind Two-Dose Placebo-Controlled Multicentre Study of 4-Hydroxy Tamoxifen Gel for Cyclical Mastalgia in Otherwise Healthy Pre-Menopausal Women With Regular Menstrual Cycles
Status:
COMPLETED
Status Verified Date:
2013-07
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 purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen 4-OHT compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women with regular menstrual cycles who are not taking oral contraceptives
Detailed Description:
This study is a Phase II randomised double-blind placebo-controlled two-dose multicentre trial of 4-OHT gel in approximately 130 otherwise healthy pre-menopausal women with a history of cyclical mastalgia peaking during the second half of the menstrual cycle and decreasing significantly with the onset of menstruation during the four months prior to study entry
The primary efficacy endpoint in this study is change in change in average pain Visual Analog Scale VAS scores for the seven worst pain scores within a cycle from baseline to the fourth cycle after start of treatment
The primary efficacy endpoint in this study is change in change in average pain Visual Analog Scale VAS scores for the seven worst pain scores within a cycle from baseline to the fourth cycle after start of treatment
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