Primary Outcome Measures:
- Change in Visual Analog Scale (VAS) scores for the seven worst scores within a cycle, from baseline to the forth
cycle after treatment
Secondary Outcome Measures:
- Change from baseline in average VAS pain scores for the seven worst pain scores within a cycle over all cycles
- Change from baseline in average VAS pain scores over all scores over all cycles
- Change from baseline in the number of nominal days of breast pain (NDBP) over all cycles using the Cardiff Breast
Pain Chart.
- Physician’s global assessment of pain.
- Physician’s clinical evaluation of mastalgia (tenderness determined by palpation).
- Physician’s clinical evaluation of mastalgia (nodularity).
- Patient’s global assessment of pain.
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.
Purpose
