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
1 other identifier
interventional
90
1 country
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2005
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedMay 9, 2014
May 1, 2014
2.5 years
June 30, 2005
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in nonmenstrual pelvic pain at end of treatment
Baseline to Week 12/Early Withdrawal Visit
Secondary Outcomes (2)
Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms
Weeks 4, 8 and 12
Safety and tolerability of DR-2001
Throughout study period
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Surgically sterilized (patient or partner), willing to use condoms throughout the study, or otherwise not at risk for pregnancy
- Diagnosis of endometriosis within the last 5 years
- Moderate or severe nonmenstrual pelvic pain
- Premenopausal
- Not pregnant or breastfeeding
- Regular (24-35 day) menstrual cycles for at least 2 months
You may not qualify if:
- Undiagnosed abnormal genital bleeding
- Any contraindication to the use of hormonal therapy
- Prior surgery for endometriosis
- GnRH analog therapy within 5 months
- Use of estrogens and/or progestins within 2 months
- Pain symptoms unrelated to endometriosis
- Any contraindication to the use of vaginal delivery systems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (41)
Duramed Investigational Site
Enterprise, Alabama, 36330, United States
Duramed Investigational Site
Montgomery, Alabama, 53717, United States
Duramed Investigational Site
Phoenix, Arizona, 85032, United States
Duramed Investigational Site
Tucson, Arizona, 85712, United States
Duramed Investigational Site
Little Rock, Arkansas, 72205, United States
Duramed Investigational Site
La Jolla, California, 92093, United States
Duramed Investigational Site
San Diego, California, 92103, United States
Duramed Investigational Site
Vista, California, 92083, United States
Duramed Investigational Site
Colorado Springs, Colorado, 80909, United States
Duramed Investigational Site
Clearwater, Florida, 33759, United States
Duramed Investigational Site
Hudson, Florida, 34667, United States
Duramed Investigational Site
Spring Hill, Florida, 34609, United States
Duramed Investigational Site
Tampa, Florida, 33606, United States
Duramed Investigational Site
West Palm Beach, Florida, 33409, United States
Duramed Investigational Site
Decatur, Georgia, 30034, United States
Duramed Investigational Site
Idaho Falls, Idaho, 83404, United States
Duramed Investigational Site
La Grange Park, Illinois, 60526, United States
Duramed Investigational Site
Maywood, Illinois, 60153, United States
Duramed Investigational Site
Oak Brook, Illinois, 60523, United States
Duramed Investigational Site
Louisville, Kentucky, 40291, United States
Duramed Investigational Site
Ann Arbor, Michigan, 48109, United States
Duramed Investigational Site
Reno, Nevada, 89502, United States
Duramed Investigational Site
Princeton, New Jersey, 08502, United States
Duramed Investigational Site
Port Jefferson, New York, 11777, United States
Duramed Investigational Site
Chapel Hill, North Carolina, 27599, United States
Duramed Investigational Site
Morganton, North Carolina, 28655, United States
Duramed Investigational Site
Winston-Salem, North Carolina, 27103, United States
Duramed Investigational Site
Columbus, Ohio, 43210, United States
Duramed Investigational Site
Dayton, Ohio, 45432, United States
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Duramed Investigational Site
Jenkintown, Pennsylvania, 36116, United States
Duramed Investigational Site
Florence, South Carolina, 29501, United States
Duramed Investigational Site
Jackson, Tennessee, 38305, United States
Duramed Investigational Site
Memphis, Tennessee, 38120, United States
Duramed Investigational Site
Austin, Texas, 78737, United States
Duramed Investigational Site
Dallas, Texas, 75231, United States
Duramed Investigational Site
San Antonio, Texas, 78229, United States
Duramed Investigational Site
Pleasant Grove, Utah, 84062, United States
Duramed Investigational Site
Sandy City, Utah, 84070, United States
Duramed Investigational Site
Norfolk, Virginia, 23607, United States
Duramed Investigational Site
Virginia Beach, Virginia, 23456, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Duramed Protocol Chair
Duramed Research, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 7, 2005
Study Start
June 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
May 9, 2014
Record last verified: 2014-05