Duloxetine for the Treatment of Chronic Pelvic Pain

• Status: Terminated
• Trial end date: 2015-11-04
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Known hypersensitivity to duloxetine or the inactive ingredients in Cymbalta;

2. 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;

3. Treatment with cytochrome P450 enzyme inhibitors;

4. Uncontrolled narrow-angle glaucoma;

5. Concurrent use of thioridazine

6. Renal Impairment (serum creatinine of 1.5 or greater)

7. History of jaundice or hepatomegaly

8. 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