Clinical trial NCT00758953: Pain Associated With Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Lumara Health, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain associated with endometriosis
timeFrame: 3 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Carmichael
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Britain
country: United States
state: Connecticut
city: West Hartford
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Hudson
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Boise
country: United States
state: Idaho
city: Champaign
country: United States
state: Illinois
city: Baton Rouge
country: United States
state: Louisiana
city: Chesterfield
country: United States
state: Missouri
city: Moorestown
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Abington
country: United States
state: Pennsylvania
city: West Chester
country: United States
state: Pennsylvania
city: Jackson
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Irving
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Kelowna
country: Canada
state: British Columbia
city: North Vancouver
country: Canada
state: British Columbia
city: Penicton
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Whitby
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
Study officials:
affiliation: Lumara Health, Inc.
name: Jim Joffrion
role: STUDY_DIRECTOR
References: