NCT00272714

Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: ASCEND Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cyclic Breast Pain, Cyclic Mastalgia

Interventions

Type	Name	Description
DRUG	Afimoxifene (0.057%) in hydroalcoholic gel

Timeline

• Start date: 2003-03-01
• Primary completion: 2004-03-01
• Completion: 2005-04-01
• First posted: 2006-01-09
• Last updated: 2023-08-16