A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland
This study is enrolling participants by invitation only.
Sponsor:
Hospital for Children and Adolescents, Finland
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
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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:
Drug Information available for:
Estrone
Testosterone propionate
Methyltestosterone
Testosterone cypionate
Testosterone
Testosterone enanthate
Testosterone undecanoate
Estropipate
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:
Detailed Description:
-
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.
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 (Child, Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623116
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
| 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:
|
Syndrome Kallmann Syndrome Disease Pathologic Processes 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 Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on September 28, 2016