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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hospital for Children and Adolescents, Finland
ClinicalTrials.gov Identifier:
NCT00623116
First received: January 11, 2008
Last updated: February 13, 2008
Last verified: January 2008
History of Changes
  Purpose

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


Condition Intervention
Kallmann Syndrome
 Drug: Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Kallmann Syndrome in Finland

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital for Children and Adolescents, Finland:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • epidemiology [ Time Frame: by 2012 (anticipated) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2007
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Kallmann syndrome
  • Age 15 yrs or more

Exclusion Criteria:

  • Severe mental retardation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623116

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

No publications provided

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
Study First Received: January 11, 2008
Last Updated: February 13, 2008
Health Authority: Finland: Ethics Committee

Keywords provided by Hospital for Children and Adolescents, Finland:
Kallmann Syndrome
hypogonadotropic hypogonadism

Additional relevant MeSH terms:
Kallmann Syndrome
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
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 19, 2013