Study Stopped
Further recruitment into the study was ceased on 10th December 2009, not attributed to safety. All patients recruited in the study completed all study visits.
A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis
A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED, PARALLEL GROUP PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF PAIN ASSOCIATED WITH ENDOMETRIOSIS
2 other identifiers
interventional
48
1 country
30
Brief Summary
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2008
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 4, 2008
CompletedStudy Start
First participant enrolled
December 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2010
CompletedResults Posted
Study results publicly available
April 30, 2021
CompletedApril 30, 2021
April 1, 2021
1.1 years
November 3, 2008
April 5, 2021
April 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Daily Endometriosis Pain Score at Week 8
Participants assessed daily endometriosis pain on an 11-point Numeric Rating Scale (NRS) of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
Baseline, Week 8
Secondary Outcomes (19)
Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16
Weeks 4, 12, and 16
Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
Baseline, Weeks 4, 8, 12, and 16
Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Baseline, Weeks 4, 8, 12, and 16
Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Baseline, Weeks 4, 8, 12, and 16
Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
Baseline, Weeks 4, 8, 12, and 16
- +14 more secondary outcomes
Study Arms (2)
Tanezumab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Pre-menstrual women with moderate to severe endometriosis. The diagnosis of endometriosis must have been confirmed surgically within the last 8 years.
- Subjects should have regular menstrual cycle (21 - 35 days) and must be willing to use adequate contraception (2 forms of birth control, one of which must be a barrier method). Contraception is required throughout the study (screening to 16 weeks post treatment), even if subjects discontinue prematurely.
You may not qualify if:
- Previous hysterectomy
- Surgical treatment for endometriosis within last 6 months.
- Medical treatment for endometriosis other than combined oral contraceptive pill within the last 3 months
- Current use of the coil or progesterone only contraceptive (the combined oral contraceptive pill is allowed).
- Any history of malignant disease (cancer)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (30)
Bay Area Physicians for Women
Mobile, Alabama, 36608, United States
Springhill Medical Center
Mobile, Alabama, 36608, United States
Wilmax Clinical Research
Mobile, Alabama, 36608, United States
Visions Clinical Research - Tucson
Tucson, Arizona, 85712, United States
Genesis Center for Clinical Research
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Visions Clinical Research
Boynton Beach, Florida, 33472, United States
Nature Coast Clinical Research, LLC
Crystal River, Florida, 34429, United States
Jacksonville Center for Clnical Research
Jacksonville, Florida, 32216, United States
Advanced Women's Healthcare
West Palm Beach, Florida, 33409, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, United States
Mount Vernon Clinical Research
Atlanta, Georgia, 30328, United States
Radiant Research
Overland Park, Kansas, 66202, United States
Women's Healthcare Group
Overland Park, Kansas, 66215, United States
N.E.C.C.R, Fall River LLC
Fall River, Massachusetts, 02720, United States
Beyer Research - Women's Health Care Specialists, PC
Paw Paw, Michigan, 49079, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510, United States
Lyndhurst Clinical Research
Kernersville, North Carolina, 27284, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Columbus Center for Women's Health Research
Columbus, Ohio, 43213, United States
Planned Parenthood of Arkansas and Eastern Oklahoma
Tulsa, Oklahoma, 74105, United States
Allegheny Pain Management
Altoona, Pennsylvania, 16602, United States
Greenville Hospital System University Medical Group, Department of OB/GYN
Greenville, South Carolina, 29605, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Whitaker's Women Care
East Ridge, Tennessee, 37412, United States
Advances In Health, Inc.
Houston, Texas, 77030, United States
Allon Health Care
Houston, Texas, 77079, United States
Old Farm Obstetrics and Gynecology
Salt Lake City, Utah, 84107, United States
Salt Lake Research
Salt Lake City, Utah, 84107, United States
Women's Clinical Research Center
Seattle, Washington, 98105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Nerve growth factor (NGF) results were reported only for plasma since a reliable assay was not available for analyzing NGF in urine. Study was prematurely terminated and recruitment was stopped due to futility shown in pre-planned interim analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2008
First Posted
November 4, 2008
Study Start
December 18, 2008
Primary Completion
January 27, 2010
Study Completion
April 5, 2010
Last Updated
April 30, 2021
Results First Posted
April 30, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.