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

NCT ID: NCT00784693

Last Updated: 2021-04-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-18

Study Completion Date

2010-04-05

Brief Summary

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

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tanezumab

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

15 mg IV single dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo IV single dose

Interventions

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Tanezumab

15 mg IV single dose

Intervention Type BIOLOGICAL

Placebo

Placebo IV single dose

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Bay Area Physicians for Women

Mobile, Alabama, United States

Site Status

Springhill Medical Center

Mobile, Alabama, United States

Site Status

Wilmax Clinical Research

Mobile, Alabama, United States

Site Status

Visions Clinical Research - Tucson

Tucson, Arizona, United States

Site Status

Genesis Center for Clinical Research

San Diego, California, United States

Site Status

Medical Center for Clinical Research

San Diego, California, United States

Site Status

Visions Clinical Research

Boynton Beach, Florida, United States

Site Status

Nature Coast Clinical Research, LLC

Crystal River, Florida, United States

Site Status

Jacksonville Center for Clnical Research

Jacksonville, Florida, United States

Site Status

Advanced Women's Healthcare

West Palm Beach, Florida, United States

Site Status

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, United States

Site Status

Mount Vernon Clinical Research

Atlanta, Georgia, United States

Site Status

Radiant Research

Overland Park, Kansas, United States

Site Status

Women's Healthcare Group

Overland Park, Kansas, United States

Site Status

N.E.C.C.R, Fall River LLC

Fall River, Massachusetts, United States

Site Status

Beyer Research - Women's Health Care Specialists, PC

Paw Paw, Michigan, United States

Site Status

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, United States

Site Status

Lyndhurst Clinical Research

Kernersville, North Carolina, United States

Site Status

Lyndhurst Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Columbus Center for Women's Health Research

Columbus, Ohio, United States

Site Status

Planned Parenthood of Arkansas and Eastern Oklahoma

Tulsa, Oklahoma, United States

Site Status

Allegheny Pain Management

Altoona, Pennsylvania, United States

Site Status

Greenville Hospital System University Medical Group, Department of OB/GYN

Greenville, South Carolina, United States

Site Status

ClinSearch, LLC

Chattanooga, Tennessee, United States

Site Status

Whitaker's Women Care

East Ridge, Tennessee, United States

Site Status

Advances In Health, Inc.

Houston, Texas, United States

Site Status

Allon Health Care

Houston, Texas, United States

Site Status

Old Farm Obstetrics and Gynecology

Salt Lake City, Utah, United States

Site Status

Salt Lake Research

Salt Lake City, Utah, United States

Site Status

Women's Clinical Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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ENDOMETRIOSIS POC

Identifier Type: OTHER

Identifier Source: secondary_id

A4091023

Identifier Type: -

Identifier Source: org_study_id

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