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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00117481
Other study ID # DR-DZL-201
Secondary ID
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


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
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Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
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