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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00318500

Enrollment

150

Registered

2006-04-26

Start date

2006-05-31

Completion date

2006-12-31

Last updated

2007-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea, Dyspareunia, Endometriosis, Pelvic Pain

Keywords

Endometriosis, Dysmenorrhea, Pelvic pain, Dyspareunia

Brief 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.

Interventions

DRUGERB-041

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026