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A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis

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NCT00784693

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endometriosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT00784693
Pfizer
Terminated
A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis

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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
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Endometriosis
  • Biological: Tanezumab
    15 mg IV single dose
  • Drug: Placebo
    Placebo IV single dose
  • Experimental: Tanezumab
    Intervention: Biological: Tanezumab
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
April 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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)
Sexes Eligible for Study: Female
18 Years to 49 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00784693
A4091023
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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