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

NCT ID: NCT00117481

Last Updated: 2014-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

DR-2001a

Intervention Type DRUG

DR-2001a administered vaginally each month

2

Group Type EXPERIMENTAL

DR-2001b

Intervention Type DRUG

DR-2001b administered vaginally each month

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo administered vaginally each month

Interventions

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DR-2001a

DR-2001a administered vaginally each month

Intervention Type DRUG

DR-2001b

DR-2001b administered vaginally each month

Intervention Type DRUG

Placebo

Placebo administered vaginally each month

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duramed Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Duramed Research, Inc.

Principal Investigators

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Duramed Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc.

Locations

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Duramed Investigational Site

Enterprise, Alabama, United States

Site Status

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Montgomery, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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La Jolla, California, United States

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San Diego, California, United States

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Vista, California, United States

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Colorado Springs, Colorado, United States

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Clearwater, Florida, United States

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Hudson, Florida, United States

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Spring Hill, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Decatur, Georgia, United States

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Idaho Falls, Idaho, United States

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La Grange Park, Illinois, United States

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Maywood, Illinois, United States

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Oak Brook, Illinois, United States

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Louisville, Kentucky, United States

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Ann Arbor, Michigan, United States

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Reno, Nevada, United States

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Princeton, New Jersey, United States

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Port Jefferson, New York, United States

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Chapel Hill, North Carolina, United States

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Morganton, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Jenkintown, Pennsylvania, United States

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Florence, South Carolina, United States

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Jackson, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Pleasant Grove, Utah, United States

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Sandy City, Utah, United States

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Norfolk, Virginia, United States

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Duramed Investigational Site

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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DR-DZL-201

Identifier Type: -

Identifier Source: org_study_id

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