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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00117481
Recruitment Status : Completed
First Posted : July 7, 2005
Last Update Posted : May 9, 2014
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: DR-2001a Drug: DR-2001b Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: DR-2001a
DR-2001a administered vaginally each month

Experimental: 2 Drug: DR-2001b
DR-2001b administered vaginally each month

Placebo Comparator: 3 Other: Placebo
Placebo administered vaginally each month




Primary Outcome Measures :
  1. Mean change in nonmenstrual pelvic pain at end of treatment [ Time Frame: Baseline to Week 12/Early Withdrawal Visit ]

Secondary Outcome Measures :
  1. Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms [ Time Frame: Weeks 4, 8 and 12 ]
  2. Safety and tolerability of DR-2001 [ Time Frame: Throughout study period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Alabama
Duramed Investigational Site
Enterprise, Alabama, United States, 36330
Duramed Investigational Site
Montgomery, Alabama, United States, 53717
United States, Arizona
Duramed Investigational Site
Phoenix, Arizona, United States, 85032
Duramed Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
Duramed Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Duramed Investigational Site
La Jolla, California, United States, 92093
Duramed Investigational Site
San Diego, California, United States, 92103
Duramed Investigational Site
Vista, California, United States, 92083
United States, Colorado
Duramed Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
Duramed Investigational Site
Clearwater, Florida, United States, 33759
Duramed Investigational Site
Hudson, Florida, United States, 34667
Duramed Investigational Site
Spring Hill, Florida, United States, 34609
Duramed Investigational Site
Tampa, Florida, United States, 33606
Duramed Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Duramed Investigational Site
Decatur, Georgia, United States, 30034
United States, Idaho
Duramed Investigational Site
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Duramed Investigational Site
Lagrange Park, Illinois, United States, 60526
Duramed Investigational Site
Maywood, Illinois, United States, 60153
Duramed Investigational Site
Oak Brook, Illinois, United States, 60523
United States, Kentucky
Duramed Investigational Site
Louisville, Kentucky, United States, 40291
United States, Michigan
Duramed Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Nevada
Duramed Investigational Site
Reno, Nevada, United States, 89502
United States, New Jersey
Duramed Investigational Site
Princeton, New Jersey, United States, 08502
United States, New York
Duramed Investigational Site
Port Jefferson, New York, United States, 11777
United States, North Carolina
Duramed Investigational Site
Chapel Hill, North Carolina, United States, 27599
Duramed Investigational Site
Morganton, North Carolina, United States, 28655
Duramed Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Duramed Investigational Site
Columbus, Ohio, United States, 43210
Duramed Investigational Site
Dayton, Ohio, United States, 45432
United States, Oklahoma
Duramed Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Duramed Investigational Site
Jenkintown, Pennsylvania, United States, 36116
United States, South Carolina
Duramed Investigational Site
Florence, South Carolina, United States, 29501
United States, Tennessee
Duramed Investigational Site
Jackson, Tennessee, United States, 38305
Duramed Investigational Site
Memphis, Tennessee, United States, 38120
United States, Texas
Duramed Investigational Site
Austin, Texas, United States, 78737
Duramed Investigational Site
Dallas, Texas, United States, 75231
Duramed Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Duramed Investigational Site
Pleasant Grove, Utah, United States, 84062
Duramed Investigational Site
Sandy, Utah, United States, 84070
United States, Virginia
Duramed Investigational Site
Norfolk, Virginia, United States, 23607
Duramed Investigational Site
Virginia Beach, Virginia, United States, 23456
Sponsors and Collaborators
Duramed Research
Investigators
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Study Chair: Duramed Protocol Chair Duramed Research, Inc.

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Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00117481    
Other Study ID Numbers: DR-DZL-201
First Posted: July 7, 2005    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014
Keywords provided by Teva Pharmaceutical Industries:
endometriosis
pelvic pain
hormonal treatment
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms