Phase 3
Completed N=324
Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Source: ClinicalTrials.gov NCT00371033 ↗
Enrolled (actual)
324
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Decrease in the NIH-CPSI Total Score by at Least 6 Points — 103; 38 Participants
◆ Published Evidence
Highly cited
104citations · ~7 / year
Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial.
Summary
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Linked Publications
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Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in the NIH-CPSI Total Score by at Least 6 Points |
103; 38 | — |
| SECONDARY Subscales of the NIH-CPSI |
19.7; 21.6; 9.1; 10.1; 3.7; 4.0 | — |
| SECONDARY Moderately or Markedly Improve on Global Response Assessment (GRA) |
68; 20 | — |
| SECONDARY Hospital Anxiety & Depression Scale |
12.4; 12.2 | — |
| SECONDARY McGill Pain Questionnaire |
9.6; 12.4 | — |
| SECONDARY Medical Outcomes Study Short Form 12 |
46.9; 44.3; 45.0; 44.6 | — |
| SECONDARY Sexual Health Inventory for Men |
16.4; 17.2 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has signed and dated the appropriate Informed Consent document.
- Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
Exclusion Criteria
- Participant has continued evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 and ≤ 100,000 CFU/ml in mid-stream urine (VB2), as demonstrated by repeat culture obtained no less than seven (7) days post antibiotic treatment.
- Participant has a calculated creatinine clearance of <60 mL/min.
- Participant has a platelet count <100,000/mm3.
- Participant is allergic to antiepileptic/antiseizure medications.
- Participant has a known allergy or sensitivity to pregabalin (Lyrica®).
- Participant is taking thiazolidinedione antidiabetic agents (i.e. rosiglitazone and pioglitazone).
- Participant has New York Heart Association Class III or IV congestive heart failure.
- Participant has a history of thrombocytopenia, or a bleeding diathesis.
- Participant has a history of prostate, bladder or urethral cancer.
- Participant has a history of alcohol abuse.
- Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
- Participant has undergone pelvic radiation or systemic chemotherapy.
- Participant has undergone intravesical chemotherapy.
- Participant has been treated with intravesical BCG.
- Participant has unilateral orchalgia without other pelvic symptoms.
- Participant has an active urethral stricture.
- Participant has a neurological disease or disorder affecting the bladder.
- Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
Data sourced from ClinicalTrials.gov (NCT00371033) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.