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Trial record 4 of 23 for:    Estropipate

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

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ClinicalTrials.gov Identifier: NCT00623116
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2008
Last Update Posted : February 25, 2008
Sponsor:
Information provided by:
Hospital for Children and Adolescents, Finland

Tracking Information
First Submitted Date  ICMJE January 11, 2008
First Posted Date  ICMJE February 25, 2008
Last Update Posted Date February 25, 2008
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2008)
epidemiology [ Time Frame: by 2012 (anticipated) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kallmann Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: February 13, 2008)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Kallmann syndrome
  • Age 15 yrs or more

Exclusion Criteria:

  • Severe mental retardation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00623116
Other Study ID Numbers  ICMJE 231408
286/E7/2007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taneli Raivio, MD, Ph D, Hospital for Children and Adolescents, Helsinki University Hospital
Study Sponsor  ICMJE Hospital for Children and Adolescents, Finland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Taneli J Raivio, MD PhD Hospital for Children and Adolescents, Helsinki University Central Hospital
PRS Account Hospital for Children and Adolescents, Finland
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP