Back to resultsA Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland
Primary Purpose
Kallmann Syndrome
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)
Sponsored by
About this trial
This is an interventional treatment trial for Kallmann Syndrome focused on measuring Kallmann Syndrome, hypogonadotropic hypogonadism
Eligibility Criteria
Inclusion Criteria:
- Kallmann syndrome
- Age 15 yrs or more
Exclusion Criteria:
- Severe mental retardation
Sites / Locations
- Hospital for Children and Adolescents, Helsinki University Central Hospital
Outcomes
Primary Outcome Measures
Clinical features including quality of life, reversibility and genetic features of Kallmann syndrome in Finland
Secondary Outcome Measures
epidemiology
Full Information
NCT ID
NCT00623116
First Posted
January 11, 2008
Last Updated
February 13, 2008
Sponsor
Hospital for Children and Adolescents, Finland
1. Study Identification
Unique Protocol Identification Number
NCT00623116
Brief Title
A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland
Official Title
Kallmann Syndrome in Finland
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital for Children and Adolescents, Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kallmann Syndrome
Keywords
Kallmann Syndrome, hypogonadotropic hypogonadism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
epidemiology
Time Frame
by 2012 (anticipated)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Kallmann syndrome
Age 15 yrs or more
Exclusion Criteria:
Severe mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taneli J Raivio, MD PhD
Organizational Affiliation
Hospital for Children and Adolescents, Helsinki University Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hospital for Children and Adolescents, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029 HUCH
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland
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