Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Precocious puberty

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    21 result(s) found for: Precocious puberty. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2015-001607-30 Sponsor Protocol Number: Debio8206-CPP-301 Start Date*: 2015-04-24
    Sponsor Name:Debiopharm International, S.A.
    Full Title: An open-label, non-comparative, multicenter study on the efficacy, safety, and pharmacokinetics of triptorelin pamoate (embonate) 22.5 mg 6-month formulation in patients suffering from central (gon...
    Medical condition: Central Precocious Puberty
    Disease: Version SOC Term Classification Code Term Level
    18.0 10014698 - Endocrine disorders 10058084 Precocious puberty PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-005644-11 Sponsor Protocol Number: 2-54-52014-143 Start Date*: 2007-07-05
    Sponsor Name:BEAUFOUR IPSEN PHARMA
    Full Title: Phase III, multicentre, non comparative, open and single stage study to assess the efficacy and safety of pamoate of triptorelin 11.25 mg in children with precocious puberty
    Medical condition: Precocious Puberty
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058084 Precocious puberty LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-002471-11 Sponsor Protocol Number: Leuprorelin-4002 Start Date*: 2022-08-08
    Sponsor Name:Takeda (China) International Trading Co., Ltd.
    Full Title: An Open Label, Multicenter, Single-arm and Prospective Study to Assess the Efficacy and Safety of Leuprorelin 3M in the Treatment of Central Precocious Puberty (CPP)
    Medical condition: Central Precocious Puberty
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004860 10073186 Central precocious puberty LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2008-000565-39 Sponsor Protocol Number: 2-54-52014-159 Start Date*: 2008-04-18
    Sponsor Name:BEAUFOUR IPSEN PHARMA
    Full Title: FOLLOW-UP OF THE PHASE III, MULTICENTRE, NON COMPARATIVE, ONE SINGLE GROUP, OPEN STUDY TO ASSESS THE LONG-TERM EFFICACY AND TOLERABILITY OF PAMOATE OF TRIPTORELIN 11.25 MG IN CHILDREN WITH PRECOCIO...
    Medical condition: Precocious Puberty
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058084 Precocious puberty LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-006766-21 Sponsor Protocol Number: MINI-SPIOMET Start Date*: 2022-09-02
    Sponsor Name:Hospital de Girona Dr. Josep Trueta
    Full Title: Towards a treatment for accelerated maturation in girls testing spiomet in a randomised placebo controlled, multicentre study.
    Medical condition: Girls with advanced puberty and accelerated bone maturation. Polycystic Ovary Syndrome (PCOS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004860 10014054 Early puberty LLT
    Population Age: Children, Under 18 Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004495-36 Sponsor Protocol Number: M90-516 Start Date*: 2014-11-28
    Sponsor Name:Abbvie previously known as Abbott
    Full Title: Study of Lupron Depot in the Treatment of Central Precocious Puberty
    Medical condition: Central Precocious Puberty
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004860 10073186 Central precocious puberty LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-004893-26 Sponsor Protocol Number: D6992C00044 Start Date*: 2007-05-03
    Sponsor Name:AstraZeneca AB
    Full Title: An open-label, non-comparative trial to evaluate the safety, efficacy and pharmacokinetics of FASLODEX (fulvestrant) in girls with progressive precocious puberty associated with McCune-Albright Syn...
    Medical condition: Progressive precocious puberty associated with McCune-Albright Syndrome
    Disease:
    Population Age: Children, Under 18 Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004493-42 Sponsor Protocol Number: L-CP07-167 Start Date*: 2014-12-03
    Sponsor Name:Abbvie previously known as Abbott
    Full Title: A Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulations in Children with Central Precocious Puberty
    Medical condition: Central Precocious Puberty
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004860 10073186 Central precocious puberty LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004494-16 Sponsor Protocol Number: L-CP07-177 Start Date*: 2014-12-03
    Sponsor Name:Abbvie previously known as Abbott
    Full Title: A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children with Central Precocious Puberty
    Medical condition: Central Precocious Puberty
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004860 10073186 Central precocious puberty LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-002963-31 Sponsor Protocol Number: D-CN-52014-243 Start Date*: 2023-01-13
    Sponsor Name:Ipsen Pharma
    Full Title: AN OPEN-LABEL, MULTICENTRE, SINGLE-ARM STUDY TO ASSESS THE EFFICACY AND SAFETY OF TRIPTORELIN 3-MONTH FORMULATION IN CHINESE CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY
    Medical condition: Central Precocious Puberty
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-003857-78 Sponsor Protocol Number: D-CN-52014-244 Start Date*: 2023-06-29
    Sponsor Name:Ipsen Pharma
    Full Title: A phase III, open-label, multicentre, single arm study to assess the efficacy and safety of the triptorelin 6-month formulation in Chinese paediatric participants with central precocious puberty
    Medical condition: Central Precocious Puberty
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-004131-61 Sponsor Protocol Number: M16-904 Start Date*: 2023-04-18
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children with Ce...
    Medical condition: Central Precocious Puberty
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001180-77 Sponsor Protocol Number: D6873C00047 Start Date*: 2012-03-07
    Sponsor Name:AstraZeneca
    Full Title: An open-label, non-comparative, multi-centre study to assess the efficacy and safety of bicalutamide when used in combination with anastrozole for the treatment of gonadotropin-independent precocio...
    Medical condition: testotoxicosis (precocious puberty)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10063654 Testotoxicosis PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2004-000384-10 Sponsor Protocol Number: D6873C00047 Start Date*: 2005-03-15
    Sponsor Name:AstraZeneca AB
    Full Title: An Open-label, non-comparative, multi-centre study to assess the efficacy and safety of bicalutamide when used in combination with anastrozole for the treatment of gonadotropin-independent precocio...
    Medical condition: testotoxicosis (familial male-limited gonadotropin-independent precocious puberty)
    Disease: Version SOC Term Classification Code Term Level
    7.1 10063654 PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-001605-24 Sponsor Protocol Number: GWND19002 Start Date*: 2020-01-15
    Sponsor Name:GW Research Ltd
    Full Title: An open-label extension trial to investigate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in patients with Rett Syndrome
    Medical condition: Rett syndrome (RTT) [typical or atypical]
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077709 Rett syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Prematurely Ended) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2014-002941-23 Sponsor Protocol Number: GWEP1423 Start Date*: 2015-09-30
    Sponsor Name:GW Research Ltd.
    Full Title: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox- Gastaut syn...
    Medical condition: Lennox-Gastaut syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-003370-27 Sponsor Protocol Number: GWND18064 Start Date*: 2019-04-09
    Sponsor Name:GW Research Ltd
    Full Title: A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett syndrome.
    Medical condition: Rett syndrome (RTT) [typical or atypical]
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077709 Rett syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-000995-24 Sponsor Protocol Number: GWEP1332 Start Date*: 2014-09-09
    Sponsor Name:GW Research Ltd
    Full Title: A double-blind, placebo-controlled two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young ...
    Medical condition: Dravet Syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10073677 Severe myoclonic epilepsy of infancy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-002939-34 Sponsor Protocol Number: GWEP1424 Start Date*: 2014-12-29
    Sponsor Name:GW Research Ltd
    Full Title: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
    Medical condition: Dravet syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10073677 Severe myoclonic epilepsy of infancy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-001834-27 Sponsor Protocol Number: GWEP1415 Start Date*: 2015-01-14
    Sponsor Name:GW Research Ltd
    Full Title: An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes
    Medical condition: Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10073677 Severe myoclonic epilepsy of infancy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) PL (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 18 20:36:44 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA