Clinical trial NCT00117481: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: endometriosis
pelvic pain
hormonal treatment
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-07-07
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change in nonmenstrual pelvic pain at end of treatment
timeFrame: Baseline to Week 12/Early Withdrawal Visit
Secondary outcomes:
measure: Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms
timeFrame: Weeks 4, 8 and 12
measure: Safety and tolerability of DR-2001
timeFrame: Throughout study period
Other outcomes:
Locations:
city: Enterprise
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Duramed Investigational Site
state: Arkansas
city: La Jolla
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: Vista
country: United States
facility: Duramed Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: Duramed Investigational Site
state: Florida
city: Hudson
country: United States
facility: Duramed Investigational Site
state: Florida
city: Spring Hill
country: United States
facility: Duramed Investigational Site
state: Florida
city: Tampa
country: United States
facility: Duramed Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: Decatur
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Idaho Falls
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Lagrange Park
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Maywood
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Ann Arbor
country: United States
facility: Duramed Investigational Site
state: Michigan
city: Reno
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Princeton
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Port Jefferson
country: United States
facility: Duramed Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Morganton
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Duramed Investigational Site
state: Oklahoma
city: Jenkintown
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Florence
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Jackson
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Duramed Investigational Site
state: Texas
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Pleasant Grove
country: United States
facility: Duramed Investigational Site
state: Utah
city: Sandy
country: United States
facility: Duramed Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Duramed Investigational Site
state: Virginia
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Protocol Chair
role: STUDY_CHAIR
References: