Recent Updates
Recently added Catalysts

DR-2001a

Phase 2

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

DR-2001a development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2001

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

DR-2001a clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about DR-2001a

What is DR-2001a used for?

DR-2001a is being developed for the treatment of endometriosis. It is a small molecule in Phase 2 clinical development. The completed Phase 2 trial evaluated DR-2001 for the management of endometriosis-related pelvic pain in adult women.

Who is developing DR-2001a?

DR-2001a is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company sponsored the Phase 2 clinical trial of the drug in endometriosis.

What phase is DR-2001a in?

DR-2001a is in Phase 2 clinical development for endometriosis. It is an investigational small molecule and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials are currently active.

What clinical trials is DR-2001a in?

DR-2001a has been studied in one completed Phase 2 trial, NCT00117481, titled Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain. The trial enrolled 90 female participants aged 18 years and older in the United States.

How was the Phase 2 trial of DR-2001a designed?

The Phase 2 trial NCT00117481 was a randomized, double-blind, placebo-controlled study. It enrolled 90 female participants aged 18 years and older with endometriosis in the United States and has been completed. The trial evaluated DR-2001 for endometriosis-related pelvic pain.