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

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DR-2001a
DR-2001b
Placebo
Sponsored by
Duramed Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, pelvic pain, hormonal treatment

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Mean change in nonmenstrual pelvic pain at end of treatment

Secondary Outcome Measures

Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms
Safety and tolerability of DR-2001

Full Information

First Posted
June 30, 2005
Last Updated
May 8, 2014
Sponsor
Duramed Research
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1. Study Identification

Unique Protocol Identification Number
NCT00117481
Brief Title
Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duramed Research

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
endometriosis, pelvic pain, hormonal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DR-2001a
Intervention Description
DR-2001a administered vaginally each month
Intervention Type
Drug
Intervention Name(s)
DR-2001b
Intervention Description
DR-2001b administered vaginally each month
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo administered vaginally each month
Primary Outcome Measure Information:
Title
Mean change in nonmenstrual pelvic pain at end of treatment
Time Frame
Baseline to Week 12/Early Withdrawal Visit
Secondary Outcome Measure Information:
Title
Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms
Time Frame
Weeks 4, 8 and 12
Title
Safety and tolerability of DR-2001
Time Frame
Throughout study period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duramed Protocol Chair
Organizational Affiliation
Duramed Research, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Duramed Investigational Site
City
Enterprise
State/Province
Alabama
ZIP/Postal Code
36330
Country
United States
Facility Name
Duramed Investigational Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
53717
Country
United States
Facility Name
Duramed Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Duramed Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Duramed Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Duramed Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Duramed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Duramed Investigational Site
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Duramed Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Duramed Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Duramed Investigational Site
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Duramed Investigational Site
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Duramed Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Duramed Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Duramed Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Duramed Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Duramed Investigational Site
City
Lagrange Park
State/Province
Illinois
ZIP/Postal Code
60526
Country
United States
Facility Name
Duramed Investigational Site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Duramed Investigational Site
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Duramed Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Duramed Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Duramed Investigational Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Duramed Investigational Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08502
Country
United States
Facility Name
Duramed Investigational Site
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
Duramed Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duramed Investigational Site
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Duramed Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Duramed Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Duramed Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Duramed Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Duramed Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
36116
Country
United States
Facility Name
Duramed Investigational Site
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Duramed Investigational Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Duramed Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Duramed Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Duramed Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Duramed Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Duramed Investigational Site
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Duramed Investigational Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Duramed Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23607
Country
United States
Facility Name
Duramed Investigational Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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