Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ASCEND Therapeutics
• Treatments: Afimoxifene

Criteria

Inclusion Criteria:

• 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 Criteria:

-