Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue

Summary

A study to determine the efficacy of 8 mg/day (4 mg/breast) of BHR-700 gel compared to placebo for reducing breast tissue density in women identified as having dense breast tissue upon analysis of screening mammography. The Primary Study Endpoint being the percent reduction of mammographic breast tissue density on a follow-up mammogram compared to the baseline mammogram after 52 weeks of treatment.

Timeline

Start

2017-08-21

Primary completion

2019-01-14

Completion

2019-04-23

Outcome

Outcome not reported

Stopped (Business): “Administrative - change in development strategy”

Drugs

Indications