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Clinical trials for Androgen Replacement Therapy

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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44380   clinical trials with a EudraCT protocol, of which   7392   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 ).  
     
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    17 result(s) found for: Androgen Replacement Therapy. Displaying page 1 of 1.
    EudraCT Number: 2011-001638-41 Sponsor Protocol Number: CLAR-09007 Start Date*: 2011-10-12
    Sponsor Name:CLARUS THERAPEUTICS, INC.
    Full Title: PHASE III, ACTIVE-CONTROLLED, SAFETY AND EFFICACY TRIAL OF ORAL TESTOSTERONE UNDECANOATE (TU) IN HYPOGONADAL MEN.
    Medical condition: Hypogonadal men
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-006925-26 Sponsor Protocol Number: no sponsor Start Date*: 2007-04-05
    Sponsor Name:Rijnstate hospital
    Full Title: Optimalising the Androgen-Oestrogen Balance in Testosterone Substituted Hypogonadal Men by Aromatase Inhibition.
    Medical condition: Men with hypogonadotropic hypogonadism treated with testosterone substitution
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004266-15 Sponsor Protocol Number: ARYHM-1 Start Date*: 2012-01-18
    Sponsor Name:RMC, Skåne University Hospital
    Full Title: Androgen replacement in young hypogonadal men: a 2 year randomized, double-blind placebo controlled study
    Medical condition: Target population: Male hypogonadism (testosterone deficiency) As end points Bone mineralisation Body composition Markers of insulin sensitivity and cardiovascular disease Lipid profile H...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10014698 - Endocrine disorders 10067734 Testosterone deficiency LLT
    Population Age: Adults Gender: Male
    Trial protocol: SE (Ongoing) NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000458-40 Sponsor Protocol Number: Infacort004 Start Date*: 2015-10-20
    Sponsor Name:Diurnal Limited
    Full Title: Open-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enr...
    Medical condition: Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. ...
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000711-40 Sponsor Protocol Number: DIUR-005 Start Date*: 2015-11-19
    Sponsor Name:Diurnal Ltd
    Full Title: A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.
    Medical condition: Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SE (Completed) NL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-005822-23 Sponsor Protocol Number: REK231814 Start Date*: 2012-10-16
    Sponsor Name:Haukeland University Hospital
    Full Title: CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA
    Medical condition: Congenital adrenal hyperplasia (CAH)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NO (Completed) SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-006114-14 Sponsor Protocol Number: 62326B1658 Start Date*: 2012-04-17
    Sponsor Name:Research and Development department
    Full Title: “Effects of testosterone on glycaemic control and other Cardiovascular Risk factors in Hypogonadal Men with uncontrolled Type 2 Diabetes: A randomized double – blinded placebo controlled add on tr...
    Medical condition: Hypogonadism Type 2 Diabetes Cardiovascular risk
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-001767-23 Sponsor Protocol Number: T01/09/13 Start Date*: 2016-02-29
    Sponsor Name:Seahorse Scientific Services Ltd.
    Full Title: A Single-Dose, Single Period, Phase II Pharmacokinetic Study To Examine TDS®-Testosterone For Its Potential To Be Inadvertently Transferred By Skin Contact After Dosing In Healthy Adult Subjects
    Medical condition: Male Hypogondism
    Disease: Version SOC Term Classification Code Term Level
    18.1 10022891 - Investigations 10055043 Blood dihydrotestosterone decreased LLT
    18.1 10022891 - Investigations 10005812 Blood testosterone abnormal PT
    18.1 10022891 - Investigations 10005811 Blood testosterone PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2005-002607-17 Sponsor Protocol Number: TSX/01/C Start Date*: 2005-11-18
    Sponsor Name:Prostrakan Pharmaceuticals Ltd
    Full Title: Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes Mellitus
    Medical condition: Male hypogonadism is generally characterised by abnormally low serum testosterone levels. Symptoms include changes in mood, decreased bone mineral density, increased body fat, decreased muscle mass...
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) ES (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002265-30 Sponsor Protocol Number: Infacort003 Start Date*: 2015-02-19
    Sponsor Name:Diurnal Limited
    Full Title: A Phase 3 open-label study of Infacort® in neonates, infants and children less than 6 years of age with adrenal insufficiency.
    Medical condition: Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. Cu...
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003142-32 Sponsor Protocol Number: TBR-760-NFPA-201 Start Date*: 2020-07-16
    Sponsor Name:Tiburio Therapeutics, Inc.
    Full Title: A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients with Non-Functioning Pituitary Adenomas
    Medical condition: Non-Functioning Pituitary Adenomas
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10035079 Pituitary adenoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) HU (Prematurely Ended) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002249-13 Sponsor Protocol Number: 3125001 Start Date*: 2019-02-04
    Sponsor Name:Orion Corporation Orion Pharma
    Full Title: SAFETY AND PHARMACOKINETICS OF ODM-209 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BRE...
    Medical condition: METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10076506 Castration-resistant prostate cancer LLT
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DK (Completed) ES (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004982-25 Sponsor Protocol Number: BET115521 Start Date*: 2015-08-18
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A phase I/II open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in subjects with NUT midline carcinoma (NMC) and othe...
    Medical condition: NUT Midline Carcinoma and other solid tumors
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10007284 Carcinoma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-001148-37 Sponsor Protocol Number: 200182 Start Date*: 2018-05-25
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A randomized, double-blind (sponsor unblind), placebo-controlled, multi-centered phase IIa study to evaluate the safety and efficacy of 13 weeks of once daily oral dosing of the selective androgen ...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-020802-13 Sponsor Protocol Number: OGX-011-10 Start Date*: 2010-12-17
    Sponsor Name:OncoGenex Technologies, Inc.
    Full Title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Clinical Benefit of Adding Custirsen to Docetaxel Retreatment/Prednisone as an Option for Secondline Therapy in Men with...
    Medical condition: metastatic castrate resistant prostate cancer. cáncer de próstata metastásico hormonoresistente
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036909 Prostate cancer metastatic LLT
    12.1 10062904 Hormone-refractory prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Ongoing) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001714-14 Sponsor Protocol Number: B7981015 Start Date*: 2019-07-22
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2B/3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR...
    Medical condition: Alopecia areata
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10001761 Alopecia areata PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) CZ (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-000345-39 Sponsor Protocol Number: B9991032 Start Date*: 2019-02-19
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumors
    Medical condition: locally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defect
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10065147 Malignant solid tumor LLT
    20.0 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) FR (Completed) BE (Completed) DK (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
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    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.

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