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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 11, 2008 | ||||
| Last Updated Date | February 13, 2008 | ||||
| Start Date ICMJE | December 2007 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00623116 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
epidemiology [ Time Frame: by 2012 (anticipated) ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland | ||||
| Official Title ICMJE | Kallmann Syndrome in Finland | ||||
| Brief Summary | Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Kallmann Syndrome | ||||
| Intervention ICMJE | Drug: Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | December 2025 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Finland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00623116 | ||||
| Responsible Party | Taneli Raivio, MD, Ph D, Hospital for Children and Adolescents, Helsinki University Hospital | ||||
| Study ID Numbers ICMJE | 231408, 286/E7/2007 | ||||
| Study Sponsor ICMJE | Hospital for Children and Adolescents, Finland | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hospital for Children and Adolescents, Finland | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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