Status:
COMPLETED
Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women
Lead Sponsor:
ASCEND Therapeutics
Conditions:
Cyclic Breast Pain, Cyclic Mastalgia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 menstr...
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 ...
Eligibility Criteria
Inclusion
- A woman is eligible for this study if she:
- is pre-menopausal and at least 18 years of age.
- has a history of cyclical mastalgia for each of the four months prior to study entry.
- moderate or severe mastalgia as determined by \>40 mm on the VAS for ≥7 days per cycle in the second part of the cycle, i.e. 13 days prior to menses and the first two days of the next cycle with a substantial decrease during the two weeks following the onset of menses, assessed during the two month run-in period.
- has a history of regular menstrual cycles of 28 plus/minus 3 days.
Exclusion
- \-
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00272714
Start Date
March 1 2003
End Date
April 1 2005
Last Update
August 16 2023
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