Clinical trial NCT00110487: Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
Official title: A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Effect of ERB-041 in the Reduction of Symptoms Associated With Endometriosis in Reproductive-Age Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-05-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry out daily activities. Qualified participants will receive no cost treatment, which may include study-related examinations, diagnostic procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified participants will also receive study medication at no cost. As a participant, the study volunteer may also experience the satisfaction of knowing she is helping the advancement of women's health care.


Eligibility criteria: Inclusion Criteria:

* Surgical diagnosis of endometriosis within 5 years
* Not pregnant and not lactating
* Willing to use non-hormonal contraception, history of regular menstrual cycles

Exclusion Criteria:

* Hysterectomy, surgical treatment for endometriosis within 3 months
* Certain medications for the treatment of endometriosis
* Previous history of a malignancy
* Abnormalities on physical or gyn exams and abnormal lab tests

Primary outcomes:
measure: To assess the effects and to compare the safety profile of an investigational
measure: medication on the relief of endometriosis-related symptoms.
Secondary outcomes:
measure: Clinical and subject assessment of symptoms related to endometriosis and the
measure: use of analgesia to relieve symptoms.
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Carmichael
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Redding
country: United States
state: California
city: San Diego
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Aventura
country: United States
state: Florida
city: Boynton
country: United States
state: Florida
city: Celebration
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Arlington Heights
country: United States
state: Illinois
city: Champaign
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Oak Brook
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Lanham
country: United States
state: Maryland
city: Laurel
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Chaska
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Greenville
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Sandy
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: