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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duramed Research

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