Duloxetine for the Treatment of Chronic Pelvic Pain

Phase 4

Terminated

Conditions: Pelvis Pain Chronic

Interventions: Drug: Placebo
Drug: Duloxetine

Registration Number: NCT01451606

Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 34

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo pill	Placebo	A pill that looks like the active drug, but does not contain any active ingredients.
Duloxetine	Duloxetine	The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).

Primary Outcome Measures

Name	Time	Method
Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).	Baseline and 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain	Baseline and 8 weeks	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.