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

Completed · Phase 2 · Has a placebo group

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT00117481

Run by

Duramed Research

People needed

90

Starts

2005-06-01

Expected to finish

2007-12-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duramed Investigational Site — Enterprise, Alabama, United States
• Duramed Investigational Site — Montgomery, Alabama, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Tucson, Arizona, United States
• Duramed Investigational Site — Little Rock, Arkansas, United States
• Duramed Investigational Site — La Jolla, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — Vista, California, United States
• Duramed Investigational Site — Colorado Springs, Colorado, United States
• Duramed Investigational Site — Clearwater, Florida, United States
• Duramed Investigational Site — Hudson, Florida, United States
• Duramed Investigational Site — Spring Hill, Florida, United States
• Duramed Investigational Site — Tampa, Florida, United States
• Duramed Investigational Site — West Palm Beach, Florida, United States
• Duramed Investigational Site — Decatur, Georgia, United States
• Duramed Investigational Site — Idaho Falls, Idaho, United States
• Duramed Investigational Site — La Grange Park, Illinois, United States
• Duramed Investigational Site — Maywood, Illinois, United States
• Duramed Investigational Site — Oak Brook, Illinois, United States
• Duramed Investigational Site — Louisville, Kentucky, United States
• Duramed Investigational Site — Ann Arbor, Michigan, United States
• Duramed Investigational Site — Reno, Nevada, United States
• Duramed Investigational Site — Princeton, New Jersey, United States
• Duramed Investigational Site — Port Jefferson, New York, United States
• Duramed Investigational Site — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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