NCT01451606

Duloxetine for the Treatment of Chronic Pelvic Pain

Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pelvis Pain Chronic

Interventions

Type	Name	Description
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
DRUG	Placebo	To serve as placebo for duloxetine. Administration schedule same as for active drug.

Timeline

• Start date: 2011-07-11
• Primary completion: 2015-11-04
• Completion: 2015-11-04
• First posted: 2011-10-13
• Last updated: 2019-09-26
• Results posted: 2018-01-23

Locations

1 site across 1 country: United States