Duloxetine for the Treatment of Chronic Pelvic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain

Conditions
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Pelvis Pain Chronic

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo pill<br>A pill that looks like the active drug, but does not contain any active ingredients. | Drug: Placebo<br>* To serve as placebo for duloxetine. Administration schedule same as for active drug.<br>* Other names: Sugar pill;|
| Active Comparator: Duloxetine<br>The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI). | Drug: Duloxetine<br>* 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<br>* Other names: Cymbalta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale). | The primary clinical efficacy measure is the change in spontaneous (non-evoked) pelvic pain from the baseline period to the end of treatment. This was assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment. Larger values (greater changes in ratings) are better outcomes. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain | This is a questionnaire assessment of functional limitations due to clinical pain. The range of scores for this subscale is 0-44. The measure is the change in score from baseline to end of treatment period. A greater number (change in score) is a better outcome. | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pelvic Pain (CPP), Pelvic Pain