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.

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

Conditions

Dysmenorrhea, Dyspareunia, Endometriosis, Pelvic Pain

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• 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 Outcome Measures:

• Change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment
• Change in rescue medication use
• Change in health related quality of life questionnaires

Study Start

May 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 45 Years
• Genders Eligible for Study: Female

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

Total Enrolment

150

Contact Details

• Randwick, New South Wales, 2031, Australia
• Sydney, New South Wales, 200, Australia
• Richmond, Victoria, 3121, Australia
• Nedlands, Western Australia, 6009, Australia

For more information, email medinfo@wyeth.com (refer to study by ClinicalTrials.gov Identifier: NCT00318500)