- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Enterprise, Alabama, United States, 36330
- Duramed Investigational Site
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Montgomery, Alabama, United States, 53717
- Duramed Investigational Site
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Arizona
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Phoenix, Arizona, United States, 85032
- Duramed Investigational Site
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Tucson, Arizona, United States, 85712
- Duramed Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Duramed Investigational Site
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California
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La Jolla, California, United States, 92093
- Duramed Investigational Site
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San Diego, California, United States, 92103
- Duramed Investigational Site
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Vista, California, United States, 92083
- Duramed Investigational Site
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Colorado
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Colorado Springs, Colorado, United States, 80909
- Duramed Investigational Site
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Florida
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Clearwater, Florida, United States, 33759
- Duramed Investigational Site
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Hudson, Florida, United States, 34667
- Duramed Investigational Site
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Spring Hill, Florida, United States, 34609
- Duramed Investigational Site
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Tampa, Florida, United States, 33606
- Duramed Investigational Site
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West Palm Beach, Florida, United States, 33409
- Duramed Investigational Site
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Georgia
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Decatur, Georgia, United States, 30034
- Duramed Investigational Site
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Duramed Investigational Site
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Illinois
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Lagrange Park, Illinois, United States, 60526
- Duramed Investigational Site
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Maywood, Illinois, United States, 60153
- Duramed Investigational Site
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Oak Brook, Illinois, United States, 60523
- Duramed Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40291
- Duramed Investigational Site
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Duramed Investigational Site
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Nevada
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Reno, Nevada, United States, 89502
- Duramed Investigational Site
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New Jersey
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Princeton, New Jersey, United States, 08502
- Duramed Investigational Site
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New York
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Port Jefferson, New York, United States, 11777
- Duramed Investigational Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Duramed Investigational Site
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Morganton, North Carolina, United States, 28655
- Duramed Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- Duramed Investigational Site
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Ohio
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Columbus, Ohio, United States, 43210
- Duramed Investigational Site
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Dayton, Ohio, United States, 45432
- Duramed Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Duramed Investigational Site
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Pennsylvania
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Jenkintown, Pennsylvania, United States, 36116
- Duramed Investigational Site
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South Carolina
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Florence, South Carolina, United States, 29501
- Duramed Investigational Site
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Tennessee
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Jackson, Tennessee, United States, 38305
- Duramed Investigational Site
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Memphis, Tennessee, United States, 38120
- Duramed Investigational Site
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Texas
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Austin, Texas, United States, 78737
- Duramed Investigational Site
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Dallas, Texas, United States, 75231
- Duramed Investigational Site
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San Antonio, Texas, United States, 78229
- Duramed Investigational Site
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Utah
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Pleasant Grove, Utah, United States, 84062
- Duramed Investigational Site
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Sandy, Utah, United States, 84070
- Duramed Investigational Site
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Virginia
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Norfolk, Virginia, United States, 23607
- Duramed Investigational Site
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Virginia Beach, Virginia, United States, 23456
- Duramed Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 1
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DR-2001a administered vaginally each month
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EXPERIMENTAL: 2
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DR-2001b administered vaginally each month
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PLACEBO_COMPARATOR: 3
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Placebo administered vaginally each month
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Mean change in nonmenstrual pelvic pain at end of treatment
Time Frame: Baseline to Week 12/Early Withdrawal Visit
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Baseline to Week 12/Early Withdrawal Visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms
Time Frame: Weeks 4, 8 and 12
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Weeks 4, 8 and 12
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Safety and tolerability of DR-2001
Time Frame: Throughout study period
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Throughout study period
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DR-DZL-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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