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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00318500




Registration number
NCT00318500
Ethics application status
Date submitted
24/04/2006
Date registered
26/04/2006
Date last updated
10/12/2007

Titles & IDs
Public title
Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
Scientific 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
Secondary ID [1] 0 0
3142A2-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysmenorrhea 0 0
Dyspareunia 0 0
Endometriosis 0 0
Pelvic Pain 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ERB-041

Treatment: Drugs: ERB-041
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment
Timepoint [1] 0 0
Secondary outcome [2] 0 0
change in rescue medication use
Timepoint [2] 0 0
Secondary outcome [3] 0 0
change in health related quality of life questionnaires
Timepoint [3] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Conditions requiring the use of chronic pain therapy

- Prophylactic use of analgesics to avoid endometriosis-related pain

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Richmond
Recruitment hospital [4] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
200 - Sydney
Recruitment postcode(s) [3] 0 0
3121 - Richmond
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
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Georgia
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United States of America
State/province [8] 0 0
Idaho
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United States of America
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Illinois
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United States of America
State/province [10] 0 0
Indiana
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
Country [16] 0 0
United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Manitoba
Country [29] 0 0
Canada
State/province [29] 0 0
Nova Scotia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Saskatchewan
Country [32] 0 0
Hong Kong
State/province [32] 0 0
Hong Kong
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South Africa
State/province [33] 0 0
Capetown
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South Africa
State/province [34] 0 0
Eastern Cape
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South Africa
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Jgb Gauteng
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South Africa
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KwaZulu Natal
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United Kingdom
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Nottinghamshire
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United Kingdom
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Scotland
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United Kingdom
State/province [39] 0 0
South Yorshire
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Wiltshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00318500
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00318500