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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110487
• Other study ID #: 3142A2-200
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2005
• Last updated: April 30, 2015
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• ERB-041

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effects and to compare the safety profile of an investigational
Primary	medication on the relief of endometriosis-related symptoms.
Secondary	Clinical and subject assessment of symptoms related to endometriosis and the
Secondary	use of analgesia to relieve symptoms.