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

Duramed Research

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: DR-2001a; Drug: DR-2001b; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117481

DR-DZL-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: DR-2001a

2

Experimental group

Treatment:

Drug: DR-2001b

3

Placebo Comparator group

Treatment:

Other: Placebo