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

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00117481

Purpose

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.

Condition	Intervention	Phase
Endometriosis	Drug: DR-2001a Drug: DR-2001b Other: Placebo	Phase II

MedlinePlus related topics: Endometriosis Pelvic Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Duramed Research:

Primary Outcome Measures:

Mean change in nonmenstrual pelvic pain at end of treatment [ Time Frame: Baseline to Week 12/Early Withdrawal Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Safety and tolerability of DR-2001 [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	June 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: DR-2001a DR-2001a administered vaginally each month
2: Experimental	Drug: DR-2001b DR-2001b administered vaginally each month
3: Placebo Comparator	Other: Placebo Placebo administered vaginally each month

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117481

Show 41 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

More Information

National Institutes of Health - Endometriosis This link exits the ClinicalTrials.gov site

Responsible Party:	Duramed Research, Inc. ( Duramed Protocol Chair )
Study ID Numbers:	DR-DZL-201
Study First Received:	June 30, 2005
Last Updated:	February 27, 2008
ClinicalTrials.gov Identifier:	NCT00117481
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

endometriosis
pelvic pain
hormonal treatment

Study placed in the following topic categories:

Genital Diseases, Female
Signs and Symptoms
Pelvic Pain
Endometriosis
Pain

ClinicalTrials.gov processed this record on January 14, 2009