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NCT Number: NCT00117481

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Duramed Investigational Site, Enterprise, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DR-2001a

Drug

DR-2001a administered vaginally each month

DR-2001b

Drug

DR-2001b administered vaginally each month

Placebo

Other

Placebo administered vaginally each month

Primary outcomes

  1. Mean change in nonmenstrual pelvic pain at end of treatment

    Time frame: Baseline to Week 12/Early Withdrawal Visit

Secondary outcomes

  1. Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms

    Time frame: Weeks 4, 8 and 12

  2. Safety and tolerability of DR-2001

    Time frame: Throughout study period

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 7, 2005
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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