Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00110487

Purpose

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 womenâ€™s health care.

Condition	Intervention	Phase
Endometriosis	Drug: ERB-041	Phase II

MedlinePlus related topics: Endometriosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Wyeth:

Primary Outcome Measures:

To assess the effects and to compare the safety profile of an investigational
medication on the relief of endometriosis-related symptoms.

Secondary Outcome Measures:

Clinical and subject assessment of symptoms related to endometriosis and the
use of analgesia to relieve symptoms.

Estimated Enrollment:	200
Study Start Date:	January 2005
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

<p>Inclusion Criteria:</p> <ul> <li>Surgical diagnosis of endometriosis within 5 years </li> <li>not pregnant and not lactating </li> <li>willing to use non-hormonal contraception, history of regular menstrual cycles.</li></ul> <p>Exclusion Criteria:</p> <ul> <li>Hysterectomy, surgical treatment for endometriosis within 3 months </li> <li>certain medications for the treatment of endometriosis </li> <li>previous history of a malignancy </li> <li>abnormalities on physical or gyn exams and abnormal lab tests </li></ul>

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110487

Show 46 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3142A2-200
Study First Received:	May 9, 2005
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00110487
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Endometriosis

Study placed in the following topic categories:

Genital Diseases, Female
Endometriosis

ClinicalTrials.gov processed this record on January 16, 2009