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

Verified by: Hospital for Children and Adolescents, Finland, January 2008
First Received: January 11, 2008 | Last Updated: February 13, 2008 | Phase: N/A | Start Date: December 2007
Overall Status: Enrolling by invitation | Estimated Enrollment: 50
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Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland...

Brief Summary

Official Title: “Kallmann Syndrome in Finland”

Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland.

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2012

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • 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 for this Clinical Trial

Primary Measures

  • 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
      Safety Issue?: No

Secondary Measures

  • epidemiology
    • Time Frame: by 2012 (anticipated)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Kallmann syndrome
  • Age 15 yrs or more

Exclusion Criteria:

  • Severe mental retardation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Hospital for Children and Adolescents, Finland Other

Overall Clinical Trial Officials and Contacts

Taneli J Raivio, MD PhD Study Director Hospital for Children and Adolescents, Helsinki University Central Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00623116

Study ID Number: 231408

ClinicalTrials.gov Identifier: NCT00623116

Health Authority: Finland: Ethics Committee

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00623116