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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	15 Years and older (Child, Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Finland
Hospital for Children and Adolescents, Helsinki University Central Hospital
Helsinki, Finland, 00029 HUCH

Sponsors and Collaborators

Hospital for Children and Adolescents, Finland

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Taneli Raivio, MD, Ph D, Hospital for Children and Adolescents, Helsinki University Hospital
ClinicalTrials.gov Identifier:	NCT00623116 History of Changes
Other Study ID Numbers:	231408; 286/E7/2007
First Posted:	February 25, 2008
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:

Syndrome; Kallmann Syndrome; Disease; Pathologic Processes; 46, XY Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Testosterone; Testosterone enanthate; Testosterone undecanoate	Testosterone 17 beta-cypionate; Methyltestosterone; Estrone; Estrogens; Estropipate; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anabolic Agents; Contraceptive Agents; Reproductive Control Agents