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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

17-beta estradiol · 1 trial · 2 indications

Phase 3 1
NCT01710696Induction of Puberty With 17-beta Estradiol in Girls With Turner SyndromeGenetic Disorder
COMPLETED50 Analytics
PHASE3COMPLETED
Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome
Genetic DisorderUnlock trial analytics

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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Frequently asked questions about 17-beta estradiol

What is 17-beta estradiol used for?

17-beta estradiol is being studied for use in girls with Turner syndrome, a genetic disorder. It is intended to induce puberty in this patient population. The drug is currently in Phase 3 clinical development and is being developed by Novo Nordisk A/S.

Who makes 17-beta estradiol?

17-beta estradiol is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the stock exchange under the ticker NVO. The drug is currently in Phase 3 clinical trials for the treatment of Turner syndrome, a genetic disorder.

What phase is 17-beta estradiol in?

17-beta estradiol is in Phase 3 clinical development. It is an investigational drug being studied for the induction of puberty in girls with Turner syndrome. The Phase 3 trial has been completed, and the drug is not yet approved for this use.

What clinical trials is 17-beta estradiol in?

17-beta estradiol has one completed Phase 3 clinical trial, identified as NCT01710696. This trial, titled 'Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome,' enrolled 50 female participants in Spain. The study was randomized, double-blind, and controlled.

Is 17-beta estradiol the same as estradiol?

17-beta estradiol is a form of estradiol, a naturally occurring estrogen hormone. In the context of this clinical development program, it is being studied specifically for its ability to induce puberty in girls with Turner syndrome. The drug is being developed by Novo Nordisk A/S.