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

NCT03199963 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2022-07-26

Study results available
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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.

Conditions

  • Mammographic Breast Density

Interventions

DRUG

4-OH tamoxifen

4-Hydroxytamoxifen (afimoxifene) gel

DRUG

Placebo

An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.

Sponsors & Collaborators

  • BHR Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · BHR Pharma, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2019-01-14
Completion
2019-04-23
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03199963 on ClinicalTrials.gov