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

NCT00318500 | Completed Phase 2

• 1 other identifier: 3142A2-203
• Study Type: interventional
• Target: 150
• Locations: 7 countries
• Sites: 70

Brief Summary

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.

Conditions

Dysmenorrhea; Dyspareunia; Endometriosis; Pelvic Pain

Keywords

Endometriosis; Dysmenorrhea; Pelvic pain; Dyspareunia

Outcome Measures

Primary Outcomes (1)

• severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator

Secondary Outcomes (3)

• change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment

• change in rescue medication use

• change in health related quality of life questionnaires

Interventions

ERB-041 DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Conditions requiring the use of chronic pain therapy
• Prophylactic use of analgesics to avoid endometriosis-related pain

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (70)

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Montgomery, Alabama, 36116, United States

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Chandler, Arizona, 85225, United States

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Phoenix, Arizona, 85032, United States

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Phoenix, Arizona, 85035, United States

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Tucson, Arizona, 85712, United States

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San Francisco, California, 94115, United States

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Vista, California, 92083, United States

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Denver, Colorado, 80202, United States

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Denver, Colorado, 80206, United States

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New Britain, Connecticut, 06050, United States

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Clearwater, Florida, 33759, United States

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New Port Richey, Florida, 34652, United States

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Plantation, Florida, 33324, United States

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Venice, Florida, 34285, United States

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West Palm Beach, Florida, 33401, United States

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West Palm Beach, Florida, 33409, United States

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Marietta, Georgia, 30066, United States

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Idaho Falls, Idaho, 83404, United States

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Oak Brook, Illinois, 60523, United States

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Evansville, Indiana, 47714, United States

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Reno, Nevada, 89502, United States

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Lawrenceville, New Jersey, 08648, United States

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Durham, North Carolina, 27710, United States

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New Bern, North Carolina, 28562, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Cleveland, Ohio, 44122, United States

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Miamisburg, Ohio, 45342, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97210, United States

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Abington, Pennsylvania, 19001, United States

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Lansdale, Pennsylvania, 19446, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Columbia, South Carolina, 29201, United States

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Greenville, South Carolina, 29607, United States

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Bristol, Tennessee, 37620, United States

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Chattanooga, Tennessee, 37403, United States

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Memphis, Tennessee, 38119, United States

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Corpus Christi, Texas, 78414, United States

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San Antonio, Texas, 78229, United States

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West Valley City, Utah, 84120, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23233, United States

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Richmond, Virginia, 23294, United States

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Virginia Beach, Virginia, 23456, United States

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Renton, Washington, 98055, United States

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Madison, Wisconsin, 53792, United States

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Randwick, New South Wales, 2031, Australia

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Sydney, New South Wales, 200, Australia

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Richmond, Victoria, 3121, Australia

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Nedlands, Western Australia, 6009, Australia

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Herestraat, Leuven, 3000, Belgium

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Calgary, Alberta, T2N 4L7, Canada

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Halifax, Nova Scotia, B3H 2N1, Canada

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London, Ontario, N6A 4V2, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Saskatoon, Saskatchewan, S7K 1N4, Canada

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Hong Kong, Hong Kong

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Cape Town, Capetown, 7925, South Africa

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Port Elizabeth, Eastern Cape, 6001, South Africa

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Roodepoort, Jgb Gauteng, 1724, South Africa

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Durban, KwaZulu-Natal, 4320, South Africa

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Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

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Glasgow, Scotland, G51 4TF, United Kingdom

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Sheffield, South Yorshire, S10 2SF, United Kingdom

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Swindon, Wiltshire, SN3 6BD, United Kingdom

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MeSH Terms

Conditions

Dysmenorrhea; Dyspareunia; Endometriosis; Pelvic Pain

Interventions

ERB 041

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For United Kingdom, ukmedinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Australia and Hong Kong, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For South Africa, ZAFinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Belgium, trials-BEL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Canada, clintrialparticipation@wyeth.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 26, 2006
• Study Start: May 1, 2006
• Study Completion: December 1, 2006
• Last Updated: December 10, 2007

Record last verified: 2007-12

Locations

BE (1); AU (4); ZA (4); GB (4); CA (7); US (49); HK (1)