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ERB-041

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

ERB-041 · 5 trials · 7 indications

Phase 2 2Phase 1 3
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.
safety, pharmacokinetics
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ERB-041DRUG -
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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 KingdomJapan
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Frequently asked questions about ERB-041

What is ERB-041 used for?

ERB-041 is an investigational small molecule being studied for Crohn's Disease, endometriosis, dysmenorrhea, and pelvic pain. It has also been evaluated in healthy volunteers for cardiac safety and pharmacokinetic studies. The drug is in clinical development by Pfizer, Inc. and is not approved for any indication.

Who is developing ERB-041?

ERB-041 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE. The drug is an investigational small molecule in clinical development for gastrointestinal and women's health conditions.

What phase is ERB-041 in?

ERB-041 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in endometriosis, which has been completed. The drug remains investigational and is not FDA approved.

What clinical trials has ERB-041 been in?

ERB-041 has been studied in four completed clinical trials. NCT00245947 evaluated the drug in active Crohn's Disease. NCT00316459 assessed cardiac repolarization effects in healthy subjects. NCT00318500 was a Phase 2 study in endometriosis symptoms. NCT00434187 evaluated multiple doses in healthy Japanese women.

Is ERB-041 the same as other drugs?

ERB-041 is a distinct investigational compound developed by Pfizer. It is not known to be the same as any other marketed drug. The clinical trials listed under its name evaluate this specific small molecule for Crohn's Disease and endometriosis-related conditions.