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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00784693
Recruitment Status : Terminated (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.)
First Posted : November 4, 2008
Last Update Posted : April 29, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.

Condition or disease Intervention/treatment Phase
Endometriosis Biological: Tanezumab Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2008
Primary Completion Date : January 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Tanezumab Biological: Tanezumab
15 mg IV single dose
Placebo Comparator: Placebo Drug: Placebo
Placebo IV single dose


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in average daily endometriosis pain over the preceding 28 days as measured by an 11-point numeric pain rating scale (NRS) derived from patient daily diary [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Average daily endometriosis pain at other time points, measured by NRS [ Time Frame: 16 weeks ]
  2. Average endometriosis pain during menstruation, average non-menstrual endometriosis pain, and average pain with intercourse, as measured by NRS [ Time Frame: 16 weeks ]
  3. Worst daily endometriosis pain, worst endometriosis pain during menstruation and worst non-menstrual endometriosis pain, as measured by NRS [ Time Frame: 16 weeks ]
  4. Patient Questionnaires: Endometriosis symptom severity score (ESSS), Endometriosis Health Profile-30 (EHP-30), Global Response Assessment (GRA) and Patient Reported Treatment Impact (PRTI) [ Time Frame: 8 weeks ]
  5. Safety endpoints: Physical examination, ECG, Pregnancy testing, clinical laboratory assessments, anti-tanezumab antibody and adverse events [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784693


  Show 25 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00784693     History of Changes
Other Study ID Numbers: A4091023
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: April 29, 2011
Last Verified: April 2011

Keywords provided by Pfizer:
Endometriosis
pain
tanezumab
nerve growth factor
questionnaires

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female