Recent Updates
Recently added Catalysts

ERB-041

Phase 2

Dysmenorrhea | Small molecule | Endocrine |Pfizer, Inc.|Trials Updated: May 1, 2015

ERB-041 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since May 2005

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment436

FDA Designations

No designations recorded

ERB-041 clinical trials

ERB-041 · 4 trials · 7 indications

Phase 2 2Phase 1 2
NCT00318500Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged WomenDysmenorrhea
COMPLETED150 Analytics
NCT00110487Study Evaluating ERB-041 in Endometriosis in Reproductive-Age WomenEndometriosis
COMPLETED200 Analytics
PHASE2COMPLETED
Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
DysmenorrheaUnlock trial analytics
PHASE2COMPLETED
Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
EndometriosisUnlock trial analytics

Study Endpoints

Primary Endpoints

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
To assess the effects and to compare the safety profile of an investigational
medication on the relief of endometriosis-related symptoms.
To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval
Inflammatory serum markers
Pharmacogenomics
Safety

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ERB-041DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersNo
Study Sites70

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 th...

Countries:United StatesAustraliaBelgiumCanadaHong KongSouth AfricaUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about ERB-041

What is ERB-041?

ERB-041 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE) for inflammatory and pain-related conditions. It has been studied in Crohn's disease, endometriosis, dysmenorrhea, and long QT syndrome. It is not approved and remains in clinical development.

What is ERB-041 used for?

ERB-041 has been studied for Crohn's disease, endometriosis, dysmenorrhea, and long QT syndrome. Clinical trials evaluated it for reducing symptoms associated with endometriosis in reproductive-aged women and for treating active Crohn's disease. It is investigational and has not been approved for any indication.

Who makes ERB-041?

Pfizer, Inc. (NYSE: PFE) is the developer of ERB-041. The company sponsored the clinical trials evaluating the drug in endometriosis, Crohn's disease, and cardiac repolarization.

What phase is ERB-041 in?

ERB-041 has been tested in Phase 1 and Phase 2 clinical trials. The Phase 1 studies evaluated it in active Crohn's disease and in healthy subjects for cardiac repolarization effects. Phase 2 studies evaluated it in endometriosis and dysmenorrhea. It is investigational and not approved.

What clinical trials is ERB-041 in?

ERB-041 has completed four clinical trials: NCT00318500 (Phase 2, endometriosis, 150 participants), NCT00316459 (Phase 1, cardiac repolarization, 64 participants), NCT00245947 (Phase 1, Crohn's disease, 22 participants), and NCT00110487 (Phase 2, endometriosis, 200 participants). All trials are completed.