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Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment (CDGP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Foundation for Paediatric Research, Finland
Information provided by (Responsible Party):
Tero Varimo, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01797718
First received: February 18, 2013
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based effective and safe treatment option. This study compares the effects of low-dose testosterone and aromatase inhibitor letrozole on pubertal progression. The hypothesis is that, in boys CDGP showing earliest signs of puberty, peroral letrozole (2.5 mg/d for 6 mo) induces faster biochemical and clinical progression of puberty as compared to low-dose intramuscular testosterone Rx (~1mg/kg/mo for 6 mo). In addition, 10 or more boys who select watchful waiting instead of medication will provide background data on the natural progression of CDGP, and their data will not be used in primary statistical comparisons.

Condition Intervention Phase
Constitutional Delay of Growth and Puberty
Drug: Testosterone
Drug: Letrozole
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • testicular volume [ Time Frame: one year ]
    Testes will be measured with a ruler to the nearest millimeter and volume will be calculated at 0, 6, and 12 mo

  • clinical and biochemical measures of pubertal progression [ Time Frame: one year ]

    Activity of the hypothalamic-pituitary-gonadal axis, evaluated by

    • genital and pubic hair stage of puberty according to Tanner;
    • growth velocity (cm/yr);
    • basal and gonadotropin-releasing hormone (GnRH)-stimulated gonadotropin levels;
    • urinary luteinizing hormone levels;
    • testosterone;
    • inhibin B;
    • anti-mullerian hormone (AMH)


Secondary Outcome Measures:
  • Bone health [ Time Frame: one year ]
    Several endpoints related to bone health

  • Psychosocial well-being [ Time Frame: one year ]
    Psycho-social well-being will assessed with questionnaires.

  • Puberty-related metabolical and clinical changes [ Time Frame: one year ]
    Biochemical and metabolical changes will be compared btw testosterone and letrozole treatment groups.


Enrollment: 35
Actual Study Start Date: October 2013
Estimated Study Completion Date: April 2018
Primary Completion Date: March 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Testosterone
~1mg/kg every 4 weeks for 6 months
Drug: Testosterone
1mg/kg every 4 weeks for 6 months
Other Name: Sustanon 250
Active Comparator: Letrozole
2.5mg daily for 6 months
Drug: Letrozole
2.5mg daily for 6 months. Safety criteria: if testosterone level is above 30nM at 3 months, the dosage is reduced to 2.5mg every other day
Other Names:
  • Letrozole Bluefish
  • Letrozole Orion
  • Letrozole Accord
  • Letrozole Sandoz
  • Femar

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Constitutional delay of growth and puberty
  • Age 14 years or more
  • mean testicular volume 2.5 ml or more and less than 4 ml
  • serum testosterone level less than 5 nM OR

as above, but serum testosterone 1 nM or more with normal DHEAS level, even if the mean testicular volume is less than 2.5 ml OR

as above, but tanner stage G2 and testosterone level less than 3 nM

Exclusion Criteria:

  • Chronic diseases
  • Primary or secondary hypogonadism
  • Chromosomal anomalies
  • Chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797718

Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Kotka Central Hospital
Kotka, Finland
Kuopio University Central Hospital
Kuopio, Finland, 70211
Turku University Central Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Helsinki University Central Hospital
Foundation for Paediatric Research, Finland
Investigators
Principal Investigator: Taneli Raivio, MD, PhD Helsinki University Central Hospital
Study Director: Matti Hero, MD, PhD Helsinki University Central Hospital
Study Chair: Tero Varimo, MD, PhD Helsinki University Central Hospital
Study Chair: Päivi Miettinen, MD, PhD Helsinki University Central Hospital
Study Chair: Jorma Toppari, MD, PhD University of Turku
Study Chair: Hanna Huopio, MD, PhD Kuopio University Central Hospital
Study Chair: Sirpa Tenhola, MD, PhD Kymeenlaakso Central Hospital
Study Chair: Raimo Voutilainen, MD, PhD Kuopio University Central Hospital
  More Information

Responsible Party: Tero Varimo, MD, PhD, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01797718     History of Changes
Other Study ID Numbers: EudraCT:2012-002477-59
Study First Received: February 18, 2013
Last Updated: March 20, 2017

Keywords provided by Helsinki University Central Hospital:
Puberty
Constitutional
Delay
Letrozole
Testosterone

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Letrozole
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on April 24, 2017