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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117481
• Other study ID #: DR-DZL-201
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: May 8, 2014
• Start date: June 2005
• Est. completion date: December 2007

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Drug:
• DR-2001a
DR-2001a administered vaginally each month
• DR-2001b
DR-2001b administered vaginally each month

Other:
• Placebo
Placebo administered vaginally each month

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Ann Arbor	Michigan
United States	Duramed Investigational Site	Austin	Texas
United States	Duramed Investigational Site	Chapel Hill	North Carolina
United States	Duramed Investigational Site	Clearwater	Florida
United States	Duramed Investigational Site	Colorado Springs	Colorado
United States	Duramed Investigational Site	Columbus	Ohio
United States	Duramed Investigational Site	Dallas	Texas
United States	Duramed Investigational Site	Dayton	Ohio
United States	Duramed Investigational Site	Decatur	Georgia
United States	Duramed Investigational Site	Enterprise	Alabama
United States	Duramed Investigational Site	Florence	South Carolina
United States	Duramed Investigational Site	Hudson	Florida
United States	Duramed Investigational Site	Idaho Falls	Idaho
United States	Duramed Investigational Site	Jackson	Tennessee
United States	Duramed Investigational Site	Jenkintown	Pennsylvania
United States	Duramed Investigational Site	La Jolla	California
United States	Duramed Investigational Site	Lagrange Park	Illinois
United States	Duramed Investigational Site	Little Rock	Arkansas
United States	Duramed Investigational Site	Louisville	Kentucky
United States	Duramed Investigational Site	Maywood	Illinois
United States	Duramed Investigational Site	Memphis	Tennessee
United States	Duramed Investigational Site	Montgomery	Alabama
United States	Duramed Investigational Site	Morganton	North Carolina
United States	Duramed Investigational Site	Norfolk	Virginia
United States	Duramed Investigational Site	Oak Brook	Illinois
United States	Duramed Investigational Site	Oklahoma City	Oklahoma
United States	Duramed Investigational Site	Phoenix	Arizona
United States	Duramed Investigational Site	Pleasant Grove	Utah
United States	Duramed Investigational Site	Port Jefferson	New York
United States	Duramed Investigational Site	Princeton	New Jersey
United States	Duramed Investigational Site	Reno	Nevada
United States	Duramed Investigational Site	San Antonio	Texas
United States	Duramed Investigational Site	San Diego	California
United States	Duramed Investigational Site	Sandy	Utah
United States	Duramed Investigational Site	Spring Hill	Florida
United States	Duramed Investigational Site	Tampa	Florida
United States	Duramed Investigational Site	Tucson	Arizona
United States	Duramed Investigational Site	Virginia Beach	Virginia
United States	Duramed Investigational Site	Vista	California
United States	Duramed Investigational Site	West Palm Beach	Florida
United States	Duramed Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in nonmenstrual pelvic pain at end of treatment		Baseline to Week 12/Early Withdrawal Visit	No
Secondary	Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms		Weeks 4, 8 and 12	No
Secondary	Safety and tolerability of DR-2001		Throughout study period	Yes