Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

NCT ID: NCT00318500

Last Updated: 2007-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-12-31

Brief Summary

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The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.

Detailed Description

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Conditions

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Dysmenorrhea Dyspareunia Endometriosis Pelvic Pain

Keywords

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Endometriosis Dysmenorrhea Pelvic pain Dyspareunia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ERB-041

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Surgical diagnosis of endometriosis within the last 10 years
* Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception

Exclusion Criteria

* Conditions requiring the use of chronic pain therapy
* Prophylactic use of analgesics to avoid endometriosis-related pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For United Kingdom, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Australia and Hong Kong, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For South Africa, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Belgium, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Canada, [email protected]

Locations

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Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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San Francisco, California, United States

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Vista, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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New Britain, Connecticut, United States

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Clearwater, Florida, United States

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New Port Richey, Florida, United States

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Plantation, Florida, United States

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Venice, Florida, United States

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West Palm Beach, Florida, United States

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West Palm Beach, Florida, United States

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Marietta, Georgia, United States

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Idaho Falls, Idaho, United States

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Oak Brook, Illinois, United States

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Evansville, Indiana, United States

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Reno, Nevada, United States

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Lawrenceville, New Jersey, United States

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Durham, North Carolina, United States

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New Bern, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Miamisburg, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Abington, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Memphis, Tennessee, United States

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Corpus Christi, Texas, United States

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San Antonio, Texas, United States

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West Valley City, Utah, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Renton, Washington, United States

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Madison, Wisconsin, United States

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Randwick, New South Wales, Australia

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Sydney, New South Wales, Australia

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Richmond, Victoria, Australia

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Nedlands, Western Australia, Australia

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Herestraat, Leuven, Belgium

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Saskatoon, Saskatchewan, Canada

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Hong Kong, , Hong Kong

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Cape Town, Capetown, South Africa

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Port Elizabeth, Eastern Cape, South Africa

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Roodepoort, Jgb Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Nottingham, Nottinghamshire, United Kingdom

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Glasgow, Scotland, United Kingdom

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Sheffield, South Yorshire, United Kingdom

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Swindon, Wiltshire, United Kingdom

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Countries

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United States Australia Belgium Canada Hong Kong South Africa United Kingdom

Other Identifiers

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3142A2-203

Identifier Type: -

Identifier Source: org_study_id