Can a nerve pain drug ease chronic pelvic pain?
NCT ID NCT00371033
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed Phase 3 trial tested whether pregabalin, a drug used for nerve pain, can reduce symptoms in men with chronic prostatitis/chronic pelvic pain syndrome. 324 participants received either pregabalin or a placebo for 6 weeks. The main goal was to see if pain scores improved significantly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pregabalin
- What this could lead to
- If it works, this could provide a new pain-relief option for men with chronic pelvic pain.
- What could go wrong
- This trial is already completed, so results are known. Pregabalin may not significantly reduce pain compared to placebo, and side effects like dizziness or drowsiness are possible.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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324 people
The number who actually took part.
- Started
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Mar 2006
- Finished
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Apr 2008
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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: * 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.
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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.
Contacts and locations
Locations
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Charles R Drew University of Medicine & Science
Los Angeles, California, 90059, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-1738, United States
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Harvard Medical School
Boston, Massachusetts, 02115, United States
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
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Queen's University
Kingston, Ontario, K7L 2V7, Canada
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Stanford University Medical Center
Stanford, California, 94305-5118, United States
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Temple University School of Medicine
Philadelphia, Pennsylvania, 19140, United States
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University of Maryland
Baltimore, Maryland, 21201, United States
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University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
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University of Washington Harborview Medical Center
Seattle, Washington, 98108, United States
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