Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain
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|ClinicalTrials.gov Identifier: NCT00117481|
Recruitment Status : Completed
First Posted : July 7, 2005
Last Update Posted : May 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Drug: DR-2001a Drug: DR-2001b Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2005|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
DR-2001a administered vaginally each month
DR-2001b administered vaginally each month
|Placebo Comparator: 3||
Placebo administered vaginally each month
- Mean change in nonmenstrual pelvic pain at end of treatment [ Time Frame: Baseline to Week 12/Early Withdrawal Visit ]
- Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms [ Time Frame: Weeks 4, 8 and 12 ]
- Safety and tolerability of DR-2001 [ Time Frame: Throughout study period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117481
Show 41 Study Locations
|Study Chair:||Duramed Protocol Chair||Duramed Research, Inc.|