NCT00117481

Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain

A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate DR-2001 for the Management of Moderate to Severe Endometriosis-Related Nonmenstrual Pelvic Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a 3-arm, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of DR-2001 in endometriosis-related symptoms, primarily nonmenstrual pelvic pain, over a 12-week treatment period.

Detailed description

This multicenter, double-blind, randomized, placebo-controlled study is designed to evaluate the ability of DR-2001 to produce beneficial changes in endometriosis-related symptoms, primarily nonmenstrual pelvic pain, over a 12-week treatment period. The overall study duration for each patient will be about 20 weeks. Patients who meet all study entrance criteria will be randomly assigned to one of three treatment groups. The change in endometriosis-related clinical symptoms will be assessed in two ways: through a combined physician/patient assessment and also with a patient self-assessment. Patients will undergo a gynecologic exam at each study visit.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	DR-2001a	DR-2001a administered vaginally each month
DRUG	DR-2001b	DR-2001b administered vaginally each month
OTHER	Placebo	Placebo administered vaginally each month

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-07-07
• Last updated: 2014-05-09

Locations

41 sites across 1 country: United States