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Pain Associated With Endometriosis

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Danazol Once Weekly
Danazol Twice Weekly
Placebo Once Weekly
Placebo Twice Weekly
Sponsored by
Lumara Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Pain associated with endometriosis

Secondary Outcome Measures

Full Information

First Posted
September 23, 2008
Last Updated
March 2, 2012
Sponsor
Lumara Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00758953
Brief Title
Pain Associated With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumara Health, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Danazol Once Weekly
Intervention Description
semi-solid
Intervention Type
Drug
Intervention Name(s)
Danazol Twice Weekly
Intervention Description
semi-solid
Intervention Type
Drug
Intervention Name(s)
Placebo Once Weekly
Intervention Description
semi-solid
Intervention Type
Drug
Intervention Name(s)
Placebo Twice Weekly
Intervention Description
semi-solid
Primary Outcome Measure Information:
Title
Pain associated with endometriosis
Time Frame
3 months of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Joffrion
Organizational Affiliation
Lumara Health, Inc.
Official's Role
Study Director
Facility Information:
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7M 2H5
Country
Canada
City
Penicton
State/Province
British Columbia
ZIP/Postal Code
V2A 5G8
Country
Canada
City
Halifax
State/Province
Ontario
ZIP/Postal Code
B3K 5R5
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1V 0Y3
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5H 3P5
Country
Canada
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1N 4V6
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8N 4X9
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 1N8
Country
Canada
City
Moscow
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation

12. IPD Sharing Statement

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Pain Associated With Endometriosis

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