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A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland

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ClinicalTrials.gov Identifier: NCT00623116
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2008
Last Update Posted : February 25, 2008
Sponsor:
Information provided by:
Hospital for Children and Adolescents, Finland

Study Description
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Brief Summary:
Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland.

Condition or disease Intervention/treatment Phase
Kallmann Syndrome Drug: Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below) Not Applicable

Detailed Description:
Kallmann syndrome is comprised of idiopathic hypogonadotropic hypogonadism and anosmia (inability to smell). Associated phenotypes may include cryptorchidism, microphallus, bone deformations, mirror movements, hearing loss and infertility. Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Kallmann Syndrome in Finland
Study Start Date : December 2007
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2025

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Arms and Interventions
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Intervention Details:
  • Drug: Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)
    clinical examination, biochemical profile, and genetic characterization. Possibility to stop hormone therapy with drugs containing testosterone (Atmos®, Testim®, Testogel®, Nebido®, Panteston®, Sustanon®), FSH (Gonal-F®, Puregon®), hCG (Pregnyl®), estrogenic compounds (such as Estrofem®, Divigel®, Estrena®, Climara®, Estradot®, Evorel®, Femseven®: Merimono®, Progynova®, Ovestin®, Zumenon®, Estrogel®, Femoston®, Femoston combi®, Divina®, Divitren®, Indivina®, Estalis sekvens®, Evorel sequi®, Novofem®, Trisekvens®, Activelle®, Estalis®, Evorel conti®, Kliogest®, Mericomb®, Mericomb Mite®, Merigest®: Angeliq®) for 3 mo to assess reversibility of GnRH-deficiency will be offered.

Outcome Measures
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Primary Outcome Measures :
  1. Clinical features including quality of life, reversibility and genetic features of Kallmann syndrome in Finland [ Time Frame: 0, 3 mo and during subsequent F/U ]

Secondary Outcome Measures :
  1. epidemiology [ Time Frame: by 2012 (anticipated) ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Kallmann syndrome
  • Age 15 yrs or more

Exclusion Criteria:

  • Severe mental retardation
Contacts and Locations
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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): NCT00623116


Locations
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Finland
Hospital for Children and Adolescents, Helsinki University Central Hospital
Helsinki, Finland, 00029 HUCH
Sponsors and Collaborators
Hospital for Children and Adolescents, Finland
Investigators
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Study Director: Taneli J Raivio, MD PhD Hospital for Children and Adolescents, Helsinki University Central Hospital
More Information
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Responsible Party: Taneli Raivio, MD, Ph D, Hospital for Children and Adolescents, Helsinki University Hospital
ClinicalTrials.gov Identifier: NCT00623116    
Other Study ID Numbers: 231408
286/E7/2007
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: February 25, 2008
Last Verified: January 2008
Keywords provided by Hospital for Children and Adolescents, Finland:
Kallmann Syndrome
hypogonadotropic hypogonadism
Additional relevant MeSH terms:
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Kallmann Syndrome
Syndrome
Disease
Pathologic Processes
Disorder of Sex Development, 46,XY
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
 Gonadal Disorders
Endocrine System Diseases
Hypogonadism
Testosterone
Estrogens
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs