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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00117481

Enrollment

Registered

2005-07-07

Start date

2005-06-30

Completion date

2007-12-31

Last updated

2014-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

endometriosis, pelvic pain, hormonal treatment

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-week treatment period.

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 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.

Interventions

DRUGDR-2001a

DR-2001a administered vaginally each month

DRUGDR-2001b

DR-2001b administered vaginally each month

OTHERPlacebo

Placebo administered vaginally each month

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Mean change in nonmenstrual pelvic pain at end of treatment	Baseline to Week 12/Early Withdrawal Visit

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026