Duloxetine for the Treatment of Chronic Pelvic Pain

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Pelvis Pain Chronic

In brief

This study is examining the effectiveness of duloxetine as a treatment for chronic pelvic pain in women. Duloxetine is FDA approved for the treatment of other pain conditions, including fibromyalgia and diabetic neuropathy.

Key facts

Study ID

NCT01451606

Run by

University of Maryland, Baltimore

People needed

34

Starts

2011-07-11

Expected to finish

2015-11-04

Last updated by the study team

2019-09-26

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• premenopausal adult women, aged 18-50
• Have chronic pelvic pain, as defined by the American College of Obstetrics and Gynecology
• Able to read and speak English

You may not qualify if…

• Chronic Pelvic Pain (CPP) only presenting in low back or vulva, or only present during menstruation or vaginal intercourse
• Self-report or documentation that all CPP sites were attributed by a prior physician to Irritable Bowel Syndromd (IBS), Interstitial cystitis (IC)/painful bladder syndrome (PBS), urinary tract infection, urinary stones, inflammatory bowel disease (ulcerative colitis or Crohn's disease), cancer or shingles.
• Currently pregnant or lactating
• A primary psychiatric diagnosis of major depression or history of suicide attempt as assessed by medical history. Also, those who would be considered to have Major Depressive Disorder (MDD) on the basis of the Diagnostic and Statistical Manual IV (DSM-IV) criteria will excluded, as well as those selecting "3" or "4" on item #9 of the Beck Depression Inventory (BDI; suicidal ideation).
• A history of bipolar disorder
• A history of seizure disorders
• Orthostatic Hypertension
• Exclusions based on the effects of duloxetine:
• Known hypersensitivity to duloxetine or the inactive ingredients in Cymbalta;
• Treatment with an monoamine oxidase inhibitor (MAOI) within 14 days of randomization, or potential need to use an MAOI during the study or within 5 days of discontinuation of the drug;
• Treatment with cytochrome P450 enzyme inhibitors;
• Uncontrolled narrow-angle glaucoma;
• Concurrent use of thioridazine
• Renal Impairment (serum creatinine of 1.5 or greater)
• History of jaundice or hepatomegaly
• Hepatic Insufficiency (elevated aspartate transaminase (AST), alanine transaminase (ALT), bilirubin, or Alkaline Phosphatase), tested at the screening period, after the first week of study medication, and again at the midpoint of the study.
• Participants who are taking Selective serotonin reuptake inhibitors (SSRIs), Selective serotonin and norepinephrine reuptake inhibitors (SSNRIs), monoamine oxidase inhibitors (MAOIs), or tricyclics within 14 days of randomization will be excluded.
• Participants who currently meet DSM-IV diagnostic criteria for Alcohol Abuse or Dependence
• Weight exceeding 285 pounds
• Hyponatremia, as determined by blood test results

Where it is running

• University of Maryland, Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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