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

May 8, 2014 updated by: Duramed Research

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Enterprise, Alabama, United States, 36330
        • Duramed Investigational Site
      • Montgomery, Alabama, United States, 53717
        • Duramed Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Duramed Investigational Site
      • Tucson, Arizona, United States, 85712
        • Duramed Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Duramed Investigational Site
    • California
      • La Jolla, California, United States, 92093
        • Duramed Investigational Site
      • San Diego, California, United States, 92103
        • Duramed Investigational Site
      • Vista, California, United States, 92083
        • Duramed Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Duramed Investigational Site
    • Florida
      • 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
        • Duramed Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Duramed Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Duramed Investigational Site
    • Illinois
      • Lagrange Park, Illinois, United States, 60526
        • Duramed Investigational Site
      • Maywood, Illinois, United States, 60153
        • Duramed Investigational Site
      • Oak Brook, Illinois, United States, 60523
        • Duramed Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40291
        • Duramed Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Duramed Investigational Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • Duramed Investigational Site
    • New Jersey
      • Princeton, New Jersey, United States, 08502
        • Duramed Investigational Site
    • New York
      • Port Jefferson, New York, United States, 11777
        • Duramed Investigational Site
    • North Carolina
      • 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
        • Duramed Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Duramed Investigational Site
      • Dayton, Ohio, United States, 45432
        • Duramed Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Duramed Investigational Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 36116
        • Duramed Investigational Site
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Duramed Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Duramed Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Duramed Investigational Site
    • Texas
      • Austin, Texas, United States, 78737
        • Duramed Investigational Site
      • Dallas, Texas, United States, 75231
        • Duramed Investigational Site
      • San Antonio, Texas, United States, 78229
        • Duramed Investigational Site
    • Utah
      • Pleasant Grove, Utah, United States, 84062
        • Duramed Investigational Site
      • Sandy, Utah, United States, 84070
        • Duramed Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23607
        • Duramed Investigational Site
      • Virginia Beach, Virginia, United States, 23456
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in nonmenstrual pelvic pain at end of treatment
Time Frame: Baseline to Week 12/Early Withdrawal Visit
Baseline to Week 12/Early Withdrawal Visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12
Safety and tolerability of DR-2001
Time Frame: Throughout study period
Throughout study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

July 6, 2005

First Posted (ESTIMATE)

July 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

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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