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DR-2021a

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00196391A Trial to Evaluate DR-2021 in Women With Secondary AmenorrheaPHASE2 COMPLETED 180 — — Sep 1, 2005Apr 1, 2007Jul 30, 201427 United States
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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 — 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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