ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


  Show 41 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
National Institutes of Health - Endometriosis  This link exits the ClinicalTrials.gov site

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00117481     History of Changes
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:
Endometriosis
Pelvic Pain
Genital Diseases, Female
 Pain
Neurologic Manifestations
Signs and Symptoms