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

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: DR-2001a; Drug: DR-2001b; Other: Placebo

• Registration Number: NCT00117481
• Lead Sponsor: Duramed Research

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-06
• Study First Posted: 2005-07-07
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DR-2001a	-
2	DR-2001b	-
3	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean change in nonmenstrual pelvic pain at end of treatment	Baseline to Week 12/Early Withdrawal Visit

Secondary Outcome Measures

Name	Time	Method
Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms	Weeks 4, 8 and 12
Safety and tolerability of DR-2001	Throughout study period

Trial Locations

Locations (1)

Duramed Investigational Site; 🇺🇸 Virginia Beach, Virginia, United States