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

Endometriosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318500
• Other study ID #: 3142A2-203
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2006
• Last updated: December 7, 2007
• Start date: May 2006
• 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: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaEuropean Union: European Medicines AgencyHong Kong: Department of HealthSouth Africa: Medicines Control CouncilUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• 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 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

Study Design

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Dyspareunia
• Endometriosis
• Pelvic Pain

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

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Hong Kong,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment
Secondary	change in rescue medication use
Secondary	change in health related quality of life questionnaires