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Completed

NCT Number: NCT00110487

Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women

The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry out daily activities. Qualified participants will receive no cost treatment, which may include study-related examinations, diagnostic procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified participants will also receive study medication at no cost. As a participant, the study volunteer may also experience the satisfaction of knowing she is helping the advancement of women's health care.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Phoenix, Arizona, United States

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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 5 years
  • Not pregnant and not lactating
  • Willing to use non-hormonal contraception, history of regular menstrual cycles

Exclusion criteria

  • Hysterectomy, surgical treatment for endometriosis within 3 months
  • Certain medications for the treatment of endometriosis
  • Previous history of a malignancy
  • Abnormalities on physical or gyn exams and abnormal lab tests

Treatment and study plan

ERB-041

Drug

Primary outcomes

  1. To assess the effects and to compare the safety profile of an investigational

  2. medication on the relief of endometriosis-related symptoms.

Secondary outcomes

  1. Clinical and subject assessment of symptoms related to endometriosis and the

  2. use of analgesia to relieve symptoms.

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, Dose-Ranging Study of the Effect of ERB-041 in the Reduction of Symptoms Associated With Endometriosis in Reproductive-Age Women

Important dates

Study start
2005
Study completion
2006
First posted
May 10, 2005
Registry last updated
May 1, 2015

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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