Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction

Completed · Early Phase 1

Conditions studied: Chronic Prostatitis With Chronic Pelvic Pain Syndrome

In brief

The objective of this study is to evaluate inhibition of mast cells and the histamine 1 receptor (H1R) for treatment of chronic prostatitis (CP) and chronic pelvic pain syndrome (CPPS).

Key facts

Study ID

NCT03167216

Run by

Northwestern University

People needed

20

Starts

2017-08-01

Expected to finish

2022-06-30

Last updated by the study team

2024-12-18

Who can join

Age: 21 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male ages 21-80 years old
• Diagnosed with Category III Chronic Pelvic Pain Syndrome
• Patients reporting pain or discomfort in any of the 8 domains of the NIH_ Chronic Prostatitis Symptom Index (NIH-CPSI).
• CP/CPPS symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
• Mast cell tryptase levels in EPS above a control threshold of 25ng/ml based on healthy men.

You may not qualify if…

• Females
• Males <21 and >80 years old
• Patients with a known hypersensitivity to cromolyn sodium or cetirizine hydrochloride
• Patients with impaired renal or hepatic function.
• Mast cell tryptase levels in EPS equal to or below a control threshold of 25ng/ml based on healthy men.

Where it is running

• Northwestern Medical Faculty Foundation — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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