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New treatment option for BPH (Benign Prostatic Hyperplasia)
Official title New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT06944145
What this study is testing
What is raloxifene?
raloxifene is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bph (benign prostatic hyperplasia).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- ≥18 yrs old on the day of study consent;
- Finasteride has been recommended for treatment of BPH by a physician;
- PSA \<20ng/ml within the last six months;
- Willingness to maintain any current genitourinary medications (e.g., beta agonists, alpha blockers, anticholinergics);
- Patient is able and willing to provide written informed consent.
You likely can't join if
- Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis;
- Previous diagnosis with any prostatic malignancy or precancerous lesions (atypical glandular foci);
- History of pelvic radiation;
- Actively receiving intravesical therapy for bladder cancer;
- Received treatment with any demethylating medications (azacitidine, decitabine, zebularine, guadecitabine, hydralazine);
- Current use of warfarin;
See the full eligibility criteria
- ≥18 yrs old on the day of study consent;
- Finasteride has been recommended for treatment of BPH by a physician;
- PSA \<20ng/ml within the last six months;
- Willingness to maintain any current genitourinary medications (e.g., beta agonists, alpha blockers, anticholinergics);
- Patient is able and willing to provide written informed consent.
- Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis;
- Previous diagnosis with any prostatic malignancy or precancerous lesions (atypical glandular foci);
- History of pelvic radiation;
- Actively receiving intravesical therapy for bladder cancer;
- Received treatment with any demethylating medications (azacitidine, decitabine, zebularine, guadecitabine, hydralazine);
- Current use of warfarin;
- Prior treatment with 5ARI medications (e.g., Finasteride or Dutasteride) in the last year;
- Diagnosed with diabetes mellitus;
- Diagnosed with any neurodegenerative diseases;
- History of allergic reaction to any intravenous (IV) iron replacement products;
- Currently taking cholestyramine medication;
- Contraindications to MRI examination, which may include:
- Cardiac pacemaker
- Intracranial clips, metal implants, or external clips within 10mm of the head
- Previous metal injury in the eye or occupation risk to ferrous metal in the eye (e.g. metalworker)
- Claustrophobia that cannot be managed with benzodiazepine
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.