Duloxetine for the Treatment of Chronic Pelvic Pain

University of Maryland Baltimore (UMB)

Status and phase

Terminated

Phase 4

Conditions

Pelvis Pain Chronic

Treatments

Drug: Placebo

Drug: Duloxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01451606

HP-00047688

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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