COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Duloxetine for the Treatment of Chronic Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01451606
Recruitment Status : Terminated (Adequate recruitment was not achieved in the time frame allowed.)
First Posted : October 13, 2011
Results First Posted : January 23, 2018
Last Update Posted : September 26, 2019
Eli Lilly and Company
Information provided by (Responsible Party):
Joel Greenspan, 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.

Condition or disease Intervention/treatment Phase
Pelvis Pain Chronic Drug: Duloxetine Drug: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.
Masking: Double (Participant, Investigator)
Masking Description: Study drug allocation was determined by University pharmacy, using a random allocation algorithm unknown by researchers or patients.
Primary Purpose: Treatment
Official Title: Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain
Actual Study Start Date : July 11, 2011
Actual Primary Completion Date : November 4, 2015
Actual Study Completion Date : November 4, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

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 Name: 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 Name: Cymbalta

Primary Outcome Measures :
  1. Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale). [ Time Frame: 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 :
  1. Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01451606

Layout table for location information
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Eli Lilly and Company
Layout table for investigator information
Principal Investigator: Joel Greenspan, Ph.D. University Of Maryland Dental School
Layout table for additonal information
Responsible Party: Joel Greenspan, Professor and Chair, University of Maryland, Baltimore Identifier: NCT01451606    
Other Study ID Numbers: HP-00047688
First Posted: October 13, 2011    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joel Greenspan, University of Maryland, Baltimore:
Chronic Pelvic Pain (CPP)
Pelvic Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents