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

NCT00623116 | Unknown

• 2 other identifiers: 231408286/E7/2007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kallmann Syndrome

Keywords

Kallmann Syndrome; hypogonadotropic hypogonadism

Outcome Measures

Primary Outcomes (1)

• Clinical features including quality of life, reversibility and genetic features of Kallmann syndrome in Finland

  0, 3 mo and during subsequent F/U

Secondary Outcomes (1)

• epidemiology

  by 2012 (anticipated)

Interventions

Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below) DRUG

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.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Kallmann syndrome
• Age 15 yrs or more

You may not qualify if:

• Severe mental retardation

Sponsors & Collaborators

• Hospital for Children and Adolescents, Finland: lead

Study Sites (1)

Hospital for Children and Adolescents, Helsinki University Central Hospital

Helsinki, 00029 HUCH, Finland

Location

MeSH Terms

Conditions

Kallmann Syndrome; Hypogonadism

Interventions

Gonadotropins; Estrogens

Condition Hierarchy (Ancestors)

Disorder of Sex Development, 46,XY; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Taneli J Raivio, MD PhD

  Hospital for Children and Adolescents, Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: February 25, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2025
• Last Updated: February 25, 2008

Record last verified: 2008-01

Locations

FI (1)