Pain Associated With Endometriosis
Sponsor
Lumara Health, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00758953
Collaborator
(none)
66
49
4
23
1.3
0.1
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Feb 1, 2007
Actual Primary Completion Date
:
Jan 1, 2009
Actual Study Completion Date
:
Jan 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: Danazol Once Weekly
semi-solid
|
| Experimental: 2
|
Drug: Danazol Twice Weekly
semi-solid
|
| Placebo Comparator: 3
|
Drug: Placebo Once Weekly
semi-solid
|
| Placebo Comparator: 4
|
Drug: Placebo Twice Weekly
semi-solid
|
Outcome Measures
Primary Outcome Measures
- Pain associated with endometriosis [3 months of treatment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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,
Exclusion Criteria:
-
Is pregnant or lactating,
-
Has a history of or has active thrombosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chandler | Arizona | United States | 85225 | |
| 2 | Phoenix | Arizona | United States | 85015 | |
| 3 | Phoenix | Arizona | United States | 85032 | |
| 4 | Little Rock | Arkansas | United States | 72205 | |
| 5 | Carmichael | California | United States | 95608 | |
| 6 | San Diego | California | United States | 92121 | |
| 7 | San Diego | California | United States | 92123 | |
| 8 | San Diego | California | United States | 92130 | |
| 9 | Denver | Colorado | United States | 80206 | |
| 10 | Britain | Connecticut | United States | 06050 | |
| 11 | West Hartford | Connecticut | United States | 06117 | |
| 12 | Aventura | Florida | United States | 33180 | |
| 13 | Boynton Beach | Florida | United States | 33437 | |
| 14 | Clearwater | Florida | United States | 33759 | |
| 15 | Hudson | Florida | United States | 34667 | |
| 16 | Tampa | Florida | United States | 33607 | |
| 17 | Alpharetta | Georgia | United States | 30005 | |
| 18 | Atlanta | Georgia | United States | 30342 | |
| 19 | Decatur | Georgia | United States | 30034 | |
| 20 | Boise | Idaho | United States | 83702 | |
| 21 | Boise | Idaho | United States | 83712 | |
| 22 | Champaign | Illinois | United States | 61820 | |
| 23 | Baton Rouge | Louisiana | United States | 70808 | |
| 24 | Chesterfield | Missouri | United States | 63017 | |
| 25 | Moorestown | New Jersey | United States | 08057 | |
| 26 | Winston-Salem | North Carolina | United States | 27103 | |
| 27 | Bismarck | North Dakota | United States | 58501 | |
| 28 | Fargo | North Dakota | United States | 58104 | |
| 29 | Cleveland | Ohio | United States | 44122 | |
| 30 | Columbus | Ohio | United States | 43231 | |
| 31 | Abington | Pennsylvania | United States | 19001 | |
| 32 | West Chester | Pennsylvania | United States | 19380 | |
| 33 | Jackson | Tennessee | United States | 38305 | |
| 34 | Memphis | Tennessee | United States | 38119 | |
| 35 | Memphis | Tennessee | United States | 38120 | |
| 36 | Nashville | Tennessee | United States | 37203 | |
| 37 | Irving | Texas | United States | 75061 | |
| 38 | Salt Lake City | Utah | United States | 84107 | |
| 39 | Kelowna | British Columbia | Canada | V1Y 3G8 | |
| 40 | North Vancouver | British Columbia | Canada | V7M 2H5 | |
| 41 | Penicton | British Columbia | Canada | V2A 5G8 | |
| 42 | Halifax | Ontario | Canada | B3K 5R5 | |
| 43 | Ottawa | Ontario | Canada | K1V 0Y3 | |
| 44 | Toronto | Ontario | Canada | M5H 3P5 | |
| 45 | Whitby | Ontario | Canada | L1N 4V6 | |
| 46 | Windsor | Ontario | Canada | N8N 4X9 | |
| 47 | Saskatoon | Saskatchewan | Canada | S7K 1N8 | |
| 48 | Moscow | Russian Federation | |||
| 49 | St. Petersburg | Russian Federation |
Sponsors and Collaborators
- Lumara Health, Inc.
Investigators
- Study Director: Jim Joffrion, Lumara Health, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lumara Health, Inc.
ClinicalTrials.gov Identifier:
NCT00758953
Other Study ID Numbers:
- DZ2-201-601-725036
First Posted:
Sep 25, 2008
Last Update Posted:
Mar 6, 2012
Last Verified:
Mar 1, 2012