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Completed

NCT Number: NCT00318500

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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Randwick, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERB-041

Drug

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

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

  2. change in rescue medication use

  3. change in health related quality of life questionnaires

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatment and Post Treatment in Reproductive-Aged Women

Important dates

Study start
2006
Study completion
2006
First posted
Apr 26, 2006
Registry last updated
Dec 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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