Duloxetine for the Treatment of Chronic Pelvic Pain
Condition: Pelvis Pain Chronic
MeSH terms: Pelvic Pain
Intervention: Duloxetine; Placebo
Intervention description: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week; To serve as placebo for duloxetine. Administration schedule same as for active drug.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.
Masking: Double (Participant, Investigator)
Masking description: Study drug allocation was determined by University pharmacy, using a random allocation algorithm unknown by researchers or patients.
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Chronic Pelvic Pain (CPP); Pelvic Pain

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.
    

Eligibility 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