Clinical trial for Benign Prostate Enlargement
Official title Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:
ClinicalTrials.gov ID: NCT07638865
What this study is testing
- What it's testing
- This study wants to see if Ralivia is safe and works better than a fake pill for treating an enlarged prostate.
- Who it's for
- The study is looking for 100 men who have been diagnosed with an enlarged prostate.
- What's involved
- Participants will take one pill by mouth every day for three months. They will also fill out questionnaires and get blood tests, urine flow checks, and ultrasound scans at 6 and 12 weeks.
- Time commitment
- The study lasts 12 weeks and requires two follow-up visits at the hospital.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80, men only
You may be able to join if
- Participant must be between 50 and 80 years old.
- Participant has signed and dated the appropriate Informed Consent document.
- International Prostate Symptom Score (IPSS) ≥8 and ≤30
- Prostate volume ≥30gram and ≤80gram
- Peak urinary flow rate (Qmax) ≥5 ml/sec and ≤15ml/sec
You likely can't join if
- Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary...
- Participant has a history of prostate, bladder or urethral cancer.
- Participant has undergone pelvic radiation or systemic chemotherapy.
- Participant has undergone intravesical chemotherapy.
- Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition (except...
- Participant has undergone prostate surgery
See the full eligibility criteria
- Participant must be between 50 and 80 years old.
- Participant has signed and dated the appropriate Informed Consent document.
- International Prostate Symptom Score (IPSS) ≥8 and ≤30
- Prostate volume ≥30gram and ≤80gram
- Peak urinary flow rate (Qmax) ≥5 ml/sec and ≤15ml/sec
- Post void residual volume ≤150ml
- Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention.
- Participant has a history of prostate, bladder or urethral cancer.
- Participant has undergone pelvic radiation or systemic chemotherapy.
- Participant has undergone intravesical chemotherapy.
- Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition (except from BPH) associated with LUTS, any neurological disease or disorder...
- Participant has undergone prostate surgery
- Participant with penile or urinary sphincter implants.
- Diagnosed neurological conditions known to affect bladder function (e.g., multiple sclerosis, Parkinson's disease, or neurogenic bladder).
- Significant medical conditions (e.g., unstable cardiac arrhythmias, uncontrolled diabetes, severe renal impairment) that pose an unreasonable risk to the patient or might interfere with study results.
- Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.
- Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
The study team makes the final eligibility decision.
Where it is enrolling
- Thessaloniki, Greece
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, but 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, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Thessaloniki, Greece. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.