Trial · NCT06944145
New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
NCT06944145, Phase 2, Recruiting, Beth Israel Deaconess Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia. Trials, record NCT06944145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06944145
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
- NCT number
- NCT06944145
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 242 participants, estimated
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- BPH (Benign Prostatic Hyperplasia), Lower Urinary Track Symptoms
- Interventions
- raloxifene, Finasteride
- First posted
- 2025-04-25
- Last updated
- 2026-03-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical response to at 12 months after study enrollment | From enrollment to the end of treatment at 12 months | 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 symptoms. |
| Secondary | Heterogeneity of clinical response to at 12 months after study enrollment by methylation score | From enrollment to the end of treatment at 12 months | Assessing 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. We will examine whether methylation score modifies the effect of treatment group on the primary endpoint by testing statistical interaction between treatment group and methylation score. The minimal International Prostate Symptom Score is 0, denoting no symptoms, and the maximum score is 35, denoting severe symptoms. |
| Secondary | Comparison of mean International Prostate Symptom Score between study arms | From enrollment to the end of treatment at 12 months | Mean 12-month International Prostate Symptom Score will be compared between study arms, adjusting for baseline International Prostate Symptom Score. The minimal International Prostate Symptom Score is 0, denoting no symptoms, and the maximum score is 35, denoting severe symptoms. |
| Secondary | Comparison of mean International Index of Erectile Function Questionnaire scores between study arms | From enrollment to the end of treatment at 12 months | Mean 12-month International Index of Erectile Function (IIEF) Questionnaire scores will be compared between study arms, adjusting for baseline International Index of Erectile Function score. A score of 0 to 5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The overall minimum score is 0, which indicates poor erectile function and the maximum score is 75 indicating good erectile function. |
| Secondary | Correlation between methylation and MRI scores | From enrollment to the end of treatment at 12 months | |
| Secondary | Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | From enrollment to the end of treatment at 12 months | Comparison of treatment related adverse events by study arm. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK142211 | New Treatment Strategies and Epigenetic Biomarker for Management of BPH | OLUMI, ARIA F | BETH ISRAEL DEACONESS MEDICAL CENTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2024 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06944145
GET https://conductscience.org/api/trials/v1/NCT06944145/registered