Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue
Public ClinicalTrials.gov record NCT03199963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo Controlled Trial of 4-Hydroxytamoxifen Gel for Reducing Breast Tissue Density in Women With BI-RADS Breast Density Categories C or D
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03199963
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 223 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 35 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 21, 2017 (Actual)
- Primary completion
- Jan 14, 2019 (Actual)
- Completion
- Apr 23, 2019 (Actual)
- Last update posted
- Jul 26, 2022
2017 – 2019
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mesa Obstetricians and Gynecologists/Cactus Clinical Research | Mesa | Arizona | 85209 | — |
| Visions Clinical Research | Tucson | Arizona | 85712 | — |
| United Clinical Research | Beverly Hills | California | 90211 | — |
| City of Hope | Duarte | California | 91010 | — |
| USC-Keck Medical Center | Los Angeles | California | 90033 | — |
| South Florida Medical Research | Aventura | Florida | 33180 | — |
| Lake OB-GYN Associates of Mid-Florida | Leesburg | Florida | 34748 | — |
| Physician Care Clinical Research, LLC | Sarasota | Florida | 34239 | — |
| Affiliated Clinical Research, Inc. | Las Vegas | Nevada | 89113 | — |
| Center for Women's Health and Wellness | Plainsboro | New Jersey | 08536 | — |
| Bosque Women Care/Cactus Clinical Research | Albuquerque | New Mexico | 87109 | — |
| Carolina Women's Research and Wellness Center | Durham | North Carolina | 27713 | — |
| Aventiv Research, Inc. | Columbus | Ohio | 43213 | — |
| Coastal Carolina Research Center, Inc. | Mt. Pleasant | South Carolina | 29464 | — |
| University of Virginia Medical Park Northridge | Charlottesville | Virginia | 22903 | — |
| Overlake Internal Medicine Associates, PS | Bellevue | Washington | 98004 | — |
| Dedicated Women's Health Specialists | Puyallup | Washington | 98372 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03199963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03199963 live on ClinicalTrials.gov.