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New treatment option for Chronic Pelvic Pain Syndrome (CPPS)
Official title Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
ClinicalTrials.gov ID: NCT07629505
What this study is testing
- What it's testing
- Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) has a huge socioeconomic impact.Presently, a ''scientific dead-end'' regarding effective treatment of CP/CPPS is reported. Promising results of clinical studies, regardless their limitations, upon efficacy of phytotherapy for CP/CPPS patients have been published .Phytotherapy is cost effective and avoids the systemic side effects of other treatments being a therapy with the possibility of repeating the treatment protocol at any time.
- Time commitment: about 5 years
- 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 18 to 50, men only
You may be able to join if
- Participant must be between 18 and 50 years old.
- Participant has signed and dated the appropriate Informed Consent document.
- Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three...
You likely can't join if
- Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
- 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...
- Participant has undergone prostate surgery or treatment.
See the full eligibility criteria
- Participant must be between 18 and 50 years old.
- Participant has signed and dated the appropriate Informed Consent document.
- Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months.
- Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
- 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 associated with LUTS, any neurological disease or disorder affecting the...
- Participant has undergone prostate surgery or treatment.
- Participant with penile or urinary sphincter implants.
- 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's taking place
- 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thessaloniki, Greece. 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.