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

Wyeth is now a wholly owned subsidiary of Pfizer150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Dysmenorrhea Dyspareunia Endometriosis Pelvic Pain

Interventions

ERB-041DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (70)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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Unnamed facility

Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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San Francisco, California, United States

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Vista, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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New Britain, Connecticut, United States

...and 60 more locations