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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Endometriosis	Drug: DR-2001a; Drug: DR-2001b; Other: Placebo	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official 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
Study Start Date :	June 2005
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1	Drug: DR-2001a; DR-2001a administered vaginally each month
Experimental: 2	Drug: DR-2001b; DR-2001b administered vaginally each month
Placebo Comparator: 3	Other: Placebo; Placebo administered vaginally each month

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Mean change in nonmenstrual pelvic pain at end of treatment [ Time Frame: Baseline to Week 12/Early Withdrawal Visit ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 41 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:	Duramed Protocol Chair	Duramed Research, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

National Institutes of Health - Endometriosis 

Responsible Party:	Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier:	NCT00117481 History of Changes
Other Study ID Numbers:	DR-DZL-201
First Posted:	July 7, 2005
Last Update Posted:	May 9, 2014
Last Verified:	May 2014

Keywords provided by Teva Pharmaceutical Industries:

endometriosis; pelvic pain; hormonal treatment

Additional relevant MeSH terms:

Endometriosis; Pelvic Pain; Genital Diseases, Female	Pain; Neurologic Manifestations; Signs and Symptoms