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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Helsinki University Central Hospital
Sponsor:
Collaborator:
Foundation for Paediatric Research, Finland
Information provided by (Responsible Party):
Tero Varimo, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01797718
First received: February 18, 2013
Last updated: March 30, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    Several endpoints related to bone health

  • Psychosocial well-being [ Time Frame: one year ] [ Designated as safety issue: No ]
    Psycho-social well-being will assessed with questionnaires.

  • Puberty-related metabolical and clinical changes [ Time Frame: one year ] [ Designated as safety issue: No ]
    Biochemical and metabolical changes will be compared btw testosterone and letrozole treatment groups.


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (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
Other Names:
  • Letrozole Bluefish
  • Letrozole Orion
  • Letrozole Accord
  • Letrozole Sandoz
  • Femar

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders 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

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

Contacts
Contact: Taneli Raivio, MD, PhD +358-9-4711 taneli.raivio@helsinki.fi
Contact: Matti Hero, MD, PhD +358-9-4711 matti.hero@hus.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
Contact: Matti Hero, MD, PhD    +35894711    matti.hero@hus.fi   
Kuopio University Central Hospital Recruiting
Kuopio, Finland, 70211
Principal Investigator: Raimo Voutilainen         
Principal Investigator: Hanna Huopio         
Turku University Central Hospital Recruiting
Turku, Finland, 20521
Principal Investigator: Jorma Toppari         
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 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: Harri Niinikoski, MD, PhD University of Turku
Study Chair: Kirsi Näntö-Salonen, MD, PhD University of Turku
Study Chair: Hanna Huopio, MD, PhD Kuopio University Central Hospital
  More Information

No publications provided

Responsible Party: Tero Varimo, 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 30, 2014
Health Authority: Finland: National Advisory Board on Health Care Ethics
Finland: Finnish National Agency for Medicines

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
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014