Status:
TERMINATED
A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis
Lead Sponsor:
Pfizer
Conditions:
Endometriosis
Eligibility:
FEMALE
18-49 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
December 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00784693
Start Date
December 18 2008
End Date
April 5 2010
Last Update
April 30 2021
Active Locations (30)
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1
Bay Area Physicians for Women
Mobile, Alabama, United States, 36608
2
Springhill Medical Center
Mobile, Alabama, United States, 36608
3
Wilmax Clinical Research
Mobile, Alabama, United States, 36608
4
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712