EndometriosisPhase 2NCT00117481
Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain
A Phase 2 study testing DR-2001a and DR-2001b in people with Endometriosis, run by Duramed Research at 41 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- DR-2001a and DR-2001b
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 41 sitesUnited States
- Study dates
- Jun 2005to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Duramed Investigational Site
Ann Arbor, Michigan, 48109
Duramed Investigational Site
Austin, Texas, 78737
Duramed Investigational Site
Chapel Hill, North Carolina, 27599
Duramed Investigational Site
Clearwater, Florida, 33759
Duramed Investigational Site
Colorado Springs, Colorado, 80909
Duramed Investigational Site
Columbus, Ohio, 43210
Duramed Investigational Site
Dallas, Texas, 75231
Duramed Investigational Site
Dayton, Ohio, 45432
Duramed Investigational Site
Decatur, Georgia, 30034
Duramed Investigational Site
Enterprise, Alabama, 36330
Duramed Investigational Site
Florence, South Carolina, 29501
Duramed Investigational Site
Hudson, Florida, 34667
Duramed Investigational Site
Idaho Falls, Idaho, 83404
Duramed Investigational Site
Jackson, Tennessee, 38305
Duramed Investigational Site
Jenkintown, Pennsylvania, 36116
Duramed Investigational Site
La Grange Park, Illinois, 60526
Duramed Investigational Site
La Jolla, California, 92093
Duramed Investigational Site
Little Rock, Arkansas, 72205
Duramed Investigational Site
Louisville, Kentucky, 40291
Duramed Investigational Site
Maywood, Illinois, 60153
Duramed Investigational Site
Memphis, Tennessee, 38120
Duramed Investigational Site
Montgomery, Alabama, 53717
Duramed Investigational Site
Morganton, North Carolina, 28655
Duramed Investigational Site
Norfolk, Virginia, 23607
Duramed Investigational Site
Oak Brook, Illinois, 60523
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112
Duramed Investigational Site
Phoenix, Arizona, 85032
Duramed Investigational Site
Pleasant Grove, Utah, 84062
Duramed Investigational Site
Port Jefferson, New York, 11777
Duramed Investigational Site
Princeton, New Jersey, 08502
Duramed Investigational Site
Reno, Nevada, 89502
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Diego, California, 92103
Duramed Investigational Site
Sandy City, Utah, 84070
Duramed Investigational Site
Spring Hill, Florida, 34609
Duramed Investigational Site
Tampa, Florida, 33606
Duramed Investigational Site
Tucson, Arizona, 85712
Duramed Investigational Site
Virginia Beach, Virginia, 23456
Duramed Investigational Site
Vista, California, 92083
Duramed Investigational Site
West Palm Beach, Florida, 33409
Duramed Investigational Site
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- DR-2001a, DR-2001b, Placebo
- Keywords
- endometriosis, pelvic pain, hormonal treatment
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR-2001aDrug
DR-2001a administered vaginally each month
DR-2001bDrug
DR-2001b administered vaginally each month
PlaceboOther
Placebo administered vaginally each month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: DR-2001a |
| 2 | Experimental | Not described Receives: Drug: DR-2001b |
| 3 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in nonmenstrual pelvic pain at end of treatment
Measured: Baseline to Week 12/Early Withdrawal Visit
Secondary outcomes (2)
Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms
Measured: Weeks 4, 8 and 12
Safety and tolerability of DR-2001
Measured: Throughout study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duramed Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Duramed Protocol Chair, Study chair, Duramed Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117481
- Sponsor's protocol ID
- DR-DZL-201
- Status last verified
- May 2014
- First submitted
- 30 Jun 2005
- Last updated
- 9 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00117481
- Acronym / sponsor ID
- DR-DZL-201
- Conditions
- Endometriosis
- Keywords
- endometriosis, pelvic pain, hormonal treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DR-2001a |
| 2 | Experimental | Drug: DR-2001b |
| 3 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DR-2001aDR-2001a administered vaginally each month | Drug | 1 |
| DR-2001bDR-2001b administered vaginally each month | Drug | 2 |
| PlaceboPlacebo administered vaginally each month | Other | 3 |
Primary outcome
Mean change in nonmenstrual pelvic pain at end of treatment
Time frame: Baseline to Week 12/Early Withdrawal Visit
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duramed Protocol Chair study chair
Duramed Research, Inc.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DR-2001a and DR-2001b in people with Endometriosis, run by Duramed Research at 41 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in nonmenstrual pelvic pain at end of treatment (time frame: Baseline to Week 12/Early Withdrawal Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.