Clinical trial NCT01451606: Duloxetine for the Treatment of Chronic Pelvic Pain
Official title: Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pelvis Pain Chronic
Keywords: Chronic Pelvic Pain (CPP)
Pelvic Pain
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2011-10-13
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University Of Maryland Dental School
name: Joel Greenspan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: