This trial is active, not recruiting.

Condition pelvis pain chronic
Treatments duloxetine, placebo
Phase phase 4
Sponsor University of Maryland
Collaborator Eli Lilly and Company
Start date June 2011
End date April 2015
Trial size 120 participants
Trial identifier NCT01451606, F1J-US-X062


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Placebo Comparator)
A pill that looks like the active drug, but does not contain any active ingredients.
placebo Sugar pill
To serve as placebo for duloxetine. Administration schedule same as for active drug.
(Active Comparator)
The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
duloxetine Cymbalta
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

Primary Outcomes

The primary clinical efficacy measure is reduction in spontaneous (non-evoked) pelvic pain. This will be assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment.
time frame: 8 weeks

Secondary Outcomes

Functional limitations due to pain
time frame: 8 weeks

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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 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 IBS, IC/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 DSM-IV criteria will excluded, as well as those selecting "3" or "4" on item #9 of the 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 AST,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 SSRIs, SSNRIs, 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

Additional Information

Official title Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain
Principal investigator Joel Greenspan, Ph.D.
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Maryland.