Duloxetine for the Treatment of Chronic Pelvic Pain

Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain

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.

Study Overview

• Status: Terminated
• Conditions: Pelvis Pain Chronic
• Intervention / Treatment: Drug: Placebo; Drug: Duloxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Joel Greenspan, Ph.D., University of Maryland Dental School

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2011
• Primary Completion (Actual): November 4, 2015
• Study Completion (Actual): November 4, 2015

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 13, 2011

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Pelvic Pain; Chronic Pelvic Pain (CPP)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: HP-00047688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No