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NCT06944145 · ClinicalTrials.gov registry record · Phase 2
New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
A Phase 2 study of BPH (Benign Prostatic Hyperplasia) and Lower Urinary Track Symptoms, sponsored by Beth Israel Deaconess Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 242
- Enrollment target
- 1
- Study location
NCT06944145: Recruiting Phase 2 study of BPH (Benign Prostatic Hyperplasia) and Lower Urinary Track Symptoms, sponsored by Beth Israel Deaconess Medical Center.
NCT06944145 is a Phase 2 study of BPH (Benign Prostatic Hyperplasia) and Lower Urinary Track Symptoms that is actively recruiting participants, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 242 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06944145, a Phase 2 study of BPH (Benign Prostatic Hyperplasia) and Lower Urinary Track Symptoms, is actively recruiting participants, sponsored by Beth Israel Deaconess Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 242 participants
- Enrollment target
- 1
- Study location
Study Summary
SRD5A2 is a critical enzyme for prostatic development and growth, and the SRD5A2 inhibitor, finasteride, is used to treat benign prostatic hyperplasia (BPH). SRD5A2 is absent in 30% of normal adult men, which explains the resistance of a subset of patients to this commonly prescribed drug. This project proposes new combination therapies (5-ARI+raloxifene) and evaluates novel non-invasive biomarkers, based on alternative pathways that lead to prostatic enlargement.
Primary Outcome
The primary endpoint is the clinical response (yes-no) to therapy at 12 months after study enrollment between the combination and monotherapy treatment groups. Clinical response will be defined as ≥3-point decrease in International Prostate Symptom Score between baseline and the 12-month timepoint, adjusting for baseline measure of International Prostate Symptom Score. The minimal International Prostate Symptom Score is 0, denoting no symptoms, and the maximum score is 35, denoting severe sympt
Conditions Studied
Interventions
- DRUG raloxifene
- DRUG Finasteride
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2025-12-03 |
| Est. Completion | 2030-08-31 |
| Phase | Phase 2 |
What NCT06944145 shows while recruiting
NCT06944145 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher).
The record links to 2 conditions, with BPH (Benign Prostatic Hyperplasia) appearing as the primary indexed condition, and to 2 interventions - of which raloxifene is the first listed.
NCT06944145 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06944145 about?
NCT06944145 is a clinical study titled "New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia". SRD5A2 is a critical enzyme for prostatic development and growth, and the SRD5A2 inhibitor, finasteride, is used to treat benign prostatic hyperplasia (BPH). SRD5A2 is absent in 30% of normal adult men, which explains the resistance of a subset of patients to this commonly prescribed drug. This proj...
What is the current status of trial NCT06944145?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 242 participants. The study started on 2025-12-03. Estimated completion is 2030-08-31.
What conditions does trial NCT06944145 study?
This clinical trial studies the following conditions: BPH (Benign Prostatic Hyperplasia), Lower Urinary Track Symptoms.
What interventions are being tested in trial NCT06944145?
The interventions under investigation include: raloxifene (DRUG), Finasteride (DRUG).
Who is sponsoring clinical trial NCT06944145?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06944145 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for BPH (Benign Prostatic Hyperplasia)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06944145's enrollment target sits among peer trials
242 237th of 2000 higher than 1,763 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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