Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Mean change in nonmenstrual pelvic pain at end of treatment [ Time Frame: Baseline to Week 12/Early Withdrawal Visit ] [ Designated as safety issue: No ]
- Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
- Safety and tolerability of DR-2001 [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
DR-2001a administered vaginally each month
DR-2001b administered vaginally each month
|Placebo Comparator: 3||
Placebo administered vaginally each month
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117481
Show 41 Study Locations
|Study Chair:||Duramed Protocol Chair||Duramed Research, Inc.|