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| Sponsored by: |
Hospital for Children and Adolescents, Finland |
|---|---|
| Information provided by: | Hospital for Children and Adolescents, Finland |
| ClinicalTrials.gov Identifier: | NCT00623116 |
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: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Kallmann Syndrome in Finland |
| 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) |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Finland | |
| Hospital for Children and Adolescents, Helsinki University Central Hospital | |
| Helsinki, Finland, 00029 HUCH | |
| Study Director: | Taneli J Raivio, MD PhD | Hospital for Children and Adolescents, Helsinki University Central Hospital |
More Information
| Responsible Party: | Hospital for Children and Adolescents, Helsinki University Hospital ( Taneli Raivio, MD, Ph D ) |
| Study ID Numbers: | 231408, 286/E7/2007 |
| Study First Received: | January 11, 2008 |
| Last Updated: | February 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00623116 History of Changes |
| Health Authority: | Finland: Ethics Committee |
|
Kallmann Syndrome hypogonadotropic hypogonadism |
|
Nervous System Malformations Gonadal Disorders Hormone Antagonists Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Estradiol 17 beta-cypionate Chorionic Gonadotropin Sex Differentiation Disorders Hormones Urogenital Abnormalities Estradiol 3-benzoate Congenital Abnormalities Polyestradiol phosphate Estrogens |
Endocrine System Diseases Kallmann Syndrome Methyltestosterone Estradiol Testosterone 17 beta-cypionate Testosterone Hypogonadism Genetic Diseases, Inborn Endocrinopathy Septo-optic Dysplasia Septo-Optic Dysplasia Estrone Androgens |
|
Estrogens Disease Gonadal Disorders Nervous System Malformations Physiological Effects of Drugs Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Kallmann Syndrome Hormones Sex Differentiation Disorders |
Pharmacologic Actions Testosterone Pathologic Processes Urogenital Abnormalities Hypogonadism Genetic Diseases, Inborn Syndrome Congenital Abnormalities Androgens Septo-Optic Dysplasia |
