Status:
COMPLETED
Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain
Lead Sponsor:
Duramed Research
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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-we...
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 nonmenstr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00117481
Start Date
June 1 2005
End Date
December 1 2007
Last Update
May 9 2014
Active Locations (41)
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1
Duramed Investigational Site
Enterprise, Alabama, United States, 36330
2
Duramed Investigational Site
Montgomery, Alabama, United States, 53717
3
Duramed Investigational Site
Phoenix, Arizona, United States, 85032
4
Duramed Investigational Site
Tucson, Arizona, United States, 85712