EndometriosisPhase 2NCT00758953
Pain Associated With Endometriosis
A Phase 2 study testing Danazol Once Weekly and Danazol Twice Weekly in people with Endometriosis, run by Lumara Health, Inc. at 49 sites in 3 countries.
Trial summary
This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Danazol Once Weekly and Danazol Twice Weekly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 49 sitesin 3 countries
- Study dates
- Feb 2007to Jan 2009
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Menstruating female 18-50 years of age,
- Regular cycle length of 21 to 35 days with menstrual bleeding that typically lasts no more than 7 days,
- Has pain associated with endometriosis,
- Has a documented history consistent with endometriosis,
Who cannot join
- Is pregnant or lactating,
- Has a history of or has active thrombosis
Trial locations and contacts
49 sites in 3 countries.
49 sites in 3 countries
United States38 sites
Study site
Abington, Pennsylvania, 19001
Study site
Alpharetta, Georgia, 30005
Study site
Atlanta, Georgia, 30342
Study site
Aventura, Florida, 33180
Study site
Baton Rouge, Louisiana, 70808
Study site
Bismarck, North Dakota, 58501
Study site
Boise, Idaho, 83702
Study site
Boise, Idaho, 83712
Study site
Boynton Beach, Florida, 33437
Study site
Britain, Connecticut, 06050
Study site
Carmichael, California, 95608
Study site
Champaign, Illinois, 61820
Study site
Chandler, Arizona, 85225
Study site
Chesterfield, Missouri, 63017
Study site
Clearwater, Florida, 33759
Study site
Cleveland, Ohio, 44122
Study site
Columbus, Ohio, 43231
Study site
Decatur, Georgia, 30034
Study site
Denver, Colorado, 80206
Study site
Fargo, North Dakota, 58104
Study site
Hudson, Florida, 34667
Study site
Irving, Texas, 75061
Study site
Jackson, Tennessee, 38305
Study site
Little Rock, Arkansas, 72205
Study site
Memphis, Tennessee, 38119
Study site
Memphis, Tennessee, 38120
Study site
Moorestown, New Jersey, 08057
Study site
Nashville, Tennessee, 37203
Study site
Phoenix, Arizona, 85015
Study site
Phoenix, Arizona, 85032
Study site
Salt Lake City, Utah, 84107
Study site
San Diego, California, 92121
Study site
San Diego, California, 92123
Study site
San Diego, California, 92130
Study site
Tampa, Florida, 33607
Study site
West Chester, Pennsylvania, 19380
Study site
West Hartford, Connecticut, 06117
Study site
Winston-Salem, North Carolina, 27103
Canada9 sites
Study site
Halifax, Ontario, B3K 5R5
Study site
Kelowna, British Columbia, V1Y 3G8
Study site
North Vancouver, British Columbia, V7M 2H5
Study site
Ottawa, Ontario, K1V 0Y3
Study site
Penicton, British Columbia, V2A 5G8
Study site
Saskatoon, Saskatchewan, S7K 1N8
Study site
Toronto, Ontario, M5H 3P5
Study site
Whitby, Ontario, L1N 4V6
Study site
Windsor, Ontario, N8N 4X9
About this study
This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.
- Conditions
- Endometriosis
- Being tested
- Danazol Once Weekly, Danazol Twice Weekly, Placebo Once Weekly, Placebo Twice Weekly
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danazol Once WeeklyDrug
semi-solid
Danazol Twice WeeklyDrug
semi-solid
Placebo Once WeeklyDrug
semi-solid
Placebo Twice WeeklyDrug
semi-solid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Danazol Once Weekly |
| 2 | Experimental | Not described Receives: Drug: Danazol Twice Weekly |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo Once Weekly |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo Twice Weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain associated with endometriosis
Measured: 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startFeb 2007
- Primary completionJan 2009
- Study completionJan 2009
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumara Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Joffrion, Study director, Lumara Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758953
- Sponsor's protocol ID
- DZ2-201-601-725036
- Status last verified
- Mar 2012
- First submitted
- 23 Sep 2008
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Associated With Endometriosis
- ClinicalTrials.gov ID
- NCT00758953
- Acronym / sponsor ID
- DZ2-201-601-725036
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Lumara Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Sep 2008 (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 study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Danazol Once Weekly |
| 2 | Experimental | Drug: Danazol Twice Weekly |
| 3 | Placebo comparator | Drug: Placebo Once Weekly |
| 4 | Placebo comparator | Drug: Placebo Twice Weekly |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Menstruating female 18-50 years of age,
- Regular cycle length of 21 to 35 days with menstrual bleeding that typically lasts no more than 7 days,
- Has pain associated with endometriosis,
- Has a documented history consistent with endometriosis,
Key exclusion criteria (2 listed)
- Is pregnant or lactating,
- Has a history of or has active thrombosis
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 |
|---|---|---|
| Danazol Once Weeklysemi-solid | Drug | 1 |
| Danazol Twice Weeklysemi-solid | Drug | 2 |
| Placebo Once Weeklysemi-solid | Drug | 3 |
| Placebo Twice Weeklysemi-solid | Drug | 4 |
Primary outcome
Pain associated with endometriosis
Time frame: 3 months of treatment
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 6 Mar 2012.
Related trials for Endometriosis
RecruitingPhase 4
Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Ovarian Endometrioma, Endometrioma
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Evaluating the Feasibility of elleFA App Implementation
Endometriosis
Recruiting
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
Endometriosis
RecruitingPhase 1
Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
Endometriosis
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.
Jim Joffrion study director
Lumara Health, Inc.
49 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Danazol Once Weekly and Danazol Twice Weekly in people with Endometriosis, run by Lumara Health, Inc. at 49 sites in 3 countries.
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 4 inclusion and 2 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 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada, Russia. 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?
Pain associated with endometriosis (time frame: 3 months of treatment). 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 6 Mar 2012.