Duloxetine for the Treatment of Chronic Pelvic Pain

Chronic pelvic pain in women can be caused by various pathologies, such as endometriosis,
fibroids, and adhesions. Surgical treatment of the pathology often relieves the pain, but a
significant number of women continue to have pain, even after visibly successful surgery. One
model explored in this study is that in some cases of chronic pelvic pain, the central
nervous system has changed in its processing of pain-related signals, requiring a therapy
directed to the Central Nervous System (CNS) to effectively treat the pain. This model has
been supported in studies of other chronic pain conditions, such as fibromyalgia and
migraine. This study will seek to determine whether the analgesic effectiveness of duloxetine
is related to the pain state of the individual.

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