Duloxetine for the Treatment of 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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain|
- 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 ] [ Designated as safety issue: No ]
- Functional limitations due to pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]A questionnaire assessment of functional limitations due to clinical pain
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo pill
A pill that looks like the active drug, but does not contain any active ingredients.
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).
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451606
|United States, Maryland|
|University of Maryland, Baltimore|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Joel Greenspan, Ph.D.||University Of Maryland Dental School|