Clinical trial NCT00318500: Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatment and Post Treatment in Reproductive-Aged Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysmenorrhea
Dyspareunia
Endometriosis
Pelvic Pain
Keywords: Endometriosis
Dysmenorrhea
Pelvic pain
Dyspareunia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.


Eligibility criteria: Inclusion Criteria:

* Surgical diagnosis of endometriosis within the last 10 years
* Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception

Exclusion Criteria:

* Conditions requiring the use of chronic pain therapy
* Prophylactic use of analgesics to avoid endometriosis-related pain

Primary outcomes:
measure: severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator
Secondary outcomes:
measure: change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment
measure: change in rescue medication use
measure: change in health related quality of life questionnaires
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: San Francisco
country: United States
state: California
city: Vista
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: New Britain
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Venice
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Oak Brook
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Reno
country: United States
state: Nevada
city: Lawrenceville
country: United States
state: New Jersey
city: Durham
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Miamisburg
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Abington
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: West Valley City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Randwick
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Richmond
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Herestraat
country: Belgium
state: Leuven
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
city: Hong Kong
country: Hong Kong
city: Cape Town
country: South Africa
state: Capetown
city: Port Elizabeth
country: South Africa
state: Eastern Cape
city: Roodepoort
country: South Africa
state: Jgb Gauteng
city: Durban
country: South Africa
state: KwaZulu Natal
city: Nottingham
country: United Kingdom
state: Nottinghamshire
city: Glasgow
country: United Kingdom
state: Scotland
city: Sheffield
country: United Kingdom
state: South Yorshire
city: Swindon
country: United Kingdom
state: Wiltshire
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For United Kingdom, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Australia and Hong Kong, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For South Africa, ZAFinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Canada, clintrialparticipation@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: