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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: DR-2001a
* Drug: DR-2001b
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DR-2001a<br>* DR-2001a administered vaginally each month<br>|
| Experimental: 2<br> | Drug: DR-2001b<br>* DR-2001b administered vaginally each month<br>|
| Placebo Comparator: 3<br> | Other: Placebo<br>* Placebo administered vaginally each month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in nonmenstrual pelvic pain at end of treatment |  | Baseline to Week 12/Early Withdrawal Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms |  | Weeks 4, 8 and 12 | 
| Safety and tolerability of DR-2001 |  | Throughout study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, pelvic pain, hormonal treatment