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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01797718
Recruitment Status : Active, not recruiting
First Posted : February 22, 2013
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Constitutional Delay of Growth and Puberty Drug: Testosterone Drug: Letrozole Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment
Actual Study Start Date : October 2013
Primary Completion Date : March 20, 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Puberty
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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 :
  1. Bone health [ Time Frame: one year ]
    Several endpoints related to bone health

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

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

Eligibility Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797718

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
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
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Tero Varimo, MD, PhD, Helsinki University Central Hospital:

Additional relevant MeSH terms:
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
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