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DR-2001a

Phase 2

Endometriosis | Small molecule | Endocrine |Teva Pharmaceutical Industries Limited|Last Updated: May 9, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

DR-2001a · 1 trial · 1 indication

Phase 2 1
NCT00117481Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic PainEndometriosis
COMPLETED90 Analytics
PHASE2COMPLETED
Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain
EndometriosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in nonmenstrual pelvic pain at end of treatment
Baseline to Week 12/Early Withdrawal Visit

Secondary Endpoints

Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms
Weeks 4, 8 and 12
Safety and tolerability of DR-2001
Throughout study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DR-2001aDRUGDR-2001a administered vaginally each month
DR-2001bDRUGDR-2001b administered vaginally each month
PlaceboOTHERPlacebo administered vaginally each month
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * Surgically sterilized (patient or partner), willing to use condoms throughout the study, or otherwise not at risk for pregnancy * Diagnosis of endometriosis within the last 5 years * Moderate or severe nonmenstrual pelvic pain * Premenopausal * Not pregnant or breastfeeding * ...

Countries:United States
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Frequently asked questions about DR-2001a

What is DR-2001a used for?

DR-2001a is an investigational small molecule being developed for the treatment of endometriosis. It is specifically being evaluated for the management of endometriosis-related pelvic pain. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does DR-2001a target?

The specific molecular target of DR-2001a has not been disclosed. It is a small molecule being studied for its potential to manage endometriosis-related pelvic pain. The drug is being developed by Teva Pharmaceutical Industries Limited.

Who makes DR-2001a?

DR-2001a is being developed by Teva Pharmaceutical Industries Limited, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol TEVA. The drug is currently in Phase 2 clinical development for the treatment of endometriosis.

What phase is DR-2001a in?

DR-2001a is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the management of endometriosis-related pelvic pain.

What clinical trials is DR-2001a in?

DR-2001a has one completed Phase 2 clinical trial, identified as NCT00117481, titled 'Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain'. This randomized, double-blind, placebo-controlled trial enrolled 90 female participants aged 18 years and older in the United States.

Is DR-2001a the same as DR-2001?

DR-2001a is the drug name used in the clinical trial record, while the trial title refers to the drug as DR-2001. These names appear to refer to the same investigational compound being developed by Teva Pharmaceutical Industries Limited for endometriosis.