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

This study has been completed.
Sponsor:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00117481
First received: June 30, 2005
Last updated: January 8, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
Endometriosis
 Drug: DR-2001a
Drug: DR-2001b
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • Mean change in nonmenstrual pelvic pain at end of treatment [ Time Frame: Baseline to Week 12/Early Withdrawal Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Safety and tolerability of DR-2001 [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: June 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117481

  Show 41 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
  More Information

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

No publications provided

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00117481     History of Changes
Other Study ID Numbers: DR-DZL-201
Study First Received: June 30, 2005
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Duramed Research:
endometriosis
pelvic pain
hormonal treatment

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013