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: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2012

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.

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

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

Lead Sponsor: Hospital for Children and Adolescents, Finland

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on August 29, 2008

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