Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain
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ClinicalTrials.gov Identifier: NCT00117481 |
Recruitment Status
:
Completed
First Posted
: July 7, 2005
Last Update Posted
: May 9, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometriosis | Drug: DR-2001a Drug: DR-2001b Other: Placebo | Phase 2 |
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 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 |
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
|
- Mean change in nonmenstrual pelvic pain at end of treatment [ Time Frame: Baseline to Week 12/Early Withdrawal Visit ]
- Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms [ Time Frame: Weeks 4, 8 and 12 ]
- Safety and tolerability of DR-2001 [ Time Frame: Throughout study period ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117481

Study Chair: | Duramed Protocol Chair | Duramed Research, Inc. |
Additional Information:
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 Key Record Dates |
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 |