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NCT03199963 · ClinicalTrials.gov registry record · Phase 3
Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue
A Phase 3 study, sponsored by BHR Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 223
- Enrollment target
NCT03199963: Clinical Trial Phase 3 study, sponsored by BHR Pharma.
NCT03199963 is a Phase 3 study that was terminated before completion, run by BHR Pharma. The registered enrollment target is 223 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03199963, a Phase 3 study, was terminated before completion, sponsored by BHR Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 223 participants
- Enrollment target
Study 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.
Primary Outcome
Percent MBD at screening compared to percent MBD after 52 weeks of treatment with either BHR-700 or Placebo.
Interventions
- DRUG Placebo
- DRUG 4-OH tamoxifen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2017-08-21 |
| Est. Completion | 2019-04-23 |
| Phase | Phase 3 |
Why NCT03199963 stopped before completion
NCT03199963 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03199963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03199963 about?
NCT03199963 is a clinical study titled "Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue". 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 ti...
What is the current status of trial NCT03199963?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 223 participants. The study started on 2017-08-21. Estimated completion is 2019-04-23.
What interventions are being tested in trial NCT03199963?
The interventions under investigation include: Placebo (DRUG), 4-OH tamoxifen (DRUG).
Who is sponsoring clinical trial NCT03199963?
This trial is sponsored by BHR Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03199963's enrollment target sits among peer trials
223 1317th of 2000 higher than 684 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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