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17-beta estradiol

Phase 3

Genetic Disorder | Small molecule | Rare Disease |Novo Nordisk A/S|Last Updated: Feb 28, 2017

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-BlindCONTROLLED
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01710696Induction of Puberty With 17-beta Estradiol in Girls With Turner SyndromePHASE3 COMPLETED 50Jul 23, 1998Jul 26, 2004Feb 28, 201728 Spain
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Study Endpoints
Primary Endpoints
Pubertal stage assesed by Tanner score
FSH (Follicle Stimulating Hormone) levels
Secondary Endpoints
Height velocity
Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair
Adverse events
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Individual doseEXPERIMENTAL -
Fixed doseEXPERIMENTAL -
Interventions
NameTypeDescription
17-beta estradiolDRUG5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally
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Eligibility Criteria
SexFEMALE
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Turner Syndrome * Treatment with growth hormone * Bone age minimum 12 years and maximum 14 years * Clear signs of ovarian insufficiency * Well documented growth rate during the last 12 months Exclusion Criteria: * Signs of spontaneous puberty * Known or suspected hypersensit...

Countries:Spain
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