Could a Two-Drug combo beat standard care for BPH?
NCT ID NCT06944145
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding raloxifene to the standard drug finasteride works better than finasteride alone for men with an enlarged prostate (BPH). About 242 adults will take either the combo or finasteride plus a placebo for 12 months. The goal is to see if the combo improves urinary symptoms more than the single drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- finasteride and raloxifene
- What this could lead to
- If successful, this combination could offer a more effective treatment option for men with BPH who don't respond to finasteride alone.
- What could go wrong
- This is a mid-stage trial with 242 participants, so results may not apply to everyone. Adding raloxifene also carries risks like blood clots, which are already listed as an exclusion.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 242 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Aug 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria 1. ≥18 yrs old on the day of study consent; 2. Finasteride has been recommended for treatment of BPH by a physician; 3. PSA \<20ng/ml within the last six months; 4. Willingness to maintain any current genitourinary medications (e.g., beta agonists, alpha blockers, anticholinergics); 5. Patient is able and willing to provide written informed consent. Exclusion criteria 1. Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis; 2. Previous diagnosis with any prostatic malignancy or precancerous lesions (atypical glandular foci); 3. History of pelvic radiation; 4. Actively receiving intravesical therapy for bladder cancer; 5. Received treatment with any demethylating medications (azacitidine, decitabine, zebularine, guadecitabine, hydralazine); 6. Current use of warfarin; 7. Prior treatment with 5ARI medications (e.g., Finasteride or Dutasteride) in the last year; 8. Diagnosed with diabetes mellitus; 9. Diagnosed with any neurodegenerative diseases; 10. History of allergic reaction to any intravenous (IV) iron replacement products; 11. Currently taking cholestyramine medication; 12. 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for BPH (benign prostatic hyperplasia) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two prostate pills instead of one: can doubling up on alpha blockers clear urine retention?
- Can a gel stop bleeding after prostate surgery and send men home the same day?
- A surgical twist that could save ejaculation during prostate surgery
- Can a smarter needle angle make prostate relief safer and easier?
- Laser vs. water jet: which surgery for enlarged prostate is better?
- Can a Needle-Free prostate treatment match implant surgery?