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DR-2021a

Phase 2

Amenorrhea | Small molecule | Endocrine |Teva Pharmaceutical Industries Limited|Last Updated: Jul 30, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

DR-2021a · 1 trial · 1 indication

Phase 2 1
NCT00196391A Trial to Evaluate DR-2021 in Women With Secondary AmenorrheaAmenorrhea
COMPLETED180 Analytics
PHASE2COMPLETED
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
AmenorrheaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
Throughout study period

Secondary Endpoints

Time to onset, duration, and severity of withdrawal bleeding.
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5EXPERIMENTAL -
6PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DR-2021aDRUG1 capsule daily for 10 days
DR-2021bDRUG1 capsule daily for 10 days
DR-2021cDRUG1 capsule daily for 10 days
DR-2021dDRUG1 capsule daily for 10 days
DR-2021eDRUG1 capsule daily for 10 days
PlaceboOTHER1 matching placebo capsule for 10 days
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Eligibility Criteria

Age Range18 Years to 50 Years
SexFEMALE
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Not pregnant * Secondary amenorrhea or oligomenorrhea of at least 50 days duration * Not currently on any hormonal medication * Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom) Exclusion Criteria: * Use an inject...

Countries:United States
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Frequently asked questions about DR-2021a

What is DR-2021a used for?

DR-2021a is an investigational small molecule being developed for the treatment of amenorrhea, specifically evaluated in women with secondary amenorrhea. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes DR-2021a?

DR-2021a is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The drug is currently in Phase 2 clinical trials for amenorrhea.

What phase is DR-2021a in?

DR-2021a is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. One Phase 2 trial has been completed for this asset.

What clinical trials is DR-2021a in?

DR-2021a has one completed Phase 2 clinical trial, identified as NCT00196391, titled 'A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea'. This randomized, double-blind, placebo-controlled study enrolled 180 female participants in the United States.

Is DR-2021a the same as DR-2021?

DR-2021a is the drug name used in the clinical trial record NCT00196391. The trial evaluates DR-2021 in women with secondary amenorrhea, and DR-2021a appears to be the same compound referenced in this study.