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

Kallmann Syndrome Clinical Trial

Official title:

Kallmann Syndrome in Finland

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00623116
• Other study ID #: 231408
• Secondary ID: 286/E7/2007
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 11, 2008
• Last updated: February 13, 2008
• Start date: December 2007
• Est. completion date: December 2025

Study information

• Verified date: January 2008
• Source: Hospital for Children and Adolescents, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Kallmann syndrome

• Age 15 yrs or more

Exclusion Criteria:

• Severe mental retardation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kallmann Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Finland	Hospital for Children and Adolescents, Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Children and Adolescents, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical features including quality of life, reversibility and genetic features of Kallmann syndrome in Finland		0, 3 mo and during subsequent F/U	No
Secondary	epidemiology		by 2012 (anticipated)	No