Kallmann SyndromeNCT00623116
A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland
A study testing Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below) in people with Kallmann Syndrome, run by Hospital for Children and Adolescents, Finland at 1 site in Finland.
Trial summary
Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kallmann Syndrome
- What is being tested?
- Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2007to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Kallmann syndrome
- Age 15 yrs or more
Who cannot join
- Severe mental retardation
Trial locations and contacts
1 site in 1 country.
Finland1 site
Hospital for Children and Adolescents, Helsinki University Central Hospital
Helsinki, 00029 HUCH
About this study
Official title: Kallmann Syndrome in Finland
Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland.
Read the 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.
- Conditions
- Kallmann Syndrome
- Being tested
- Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)
- Keywords
- Kallmann Syndrome, hypogonadotropic hypogonadism
- Medical subject headings
- Kallmann Syndrome, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)Drug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical features including quality of life, reversibility and genetic features of Kallmann syndrome in Finland
Measured: 0, 3 mo and during subsequent F/U
Secondary outcomes (1)
epidemiology
Measured: by 2012 (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2012 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kallmann SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Children and Adolescents, Finland
- Sponsor type
- University, hospital or other
- Investigators
- Taneli J Raivio, MD PhD, Study director, Hospital for Children and Adolescents, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623116
- Sponsor's protocol ID
- 231408
- Other IDs
- 286/E7/2007
- Status last verified
- Jan 2008
- First submitted
- 11 Jan 2008
- Last updated
- 25 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kallmann Syndrome in Finland
- ClinicalTrials.gov ID
- NCT00623116
- Acronym / sponsor ID
- 231408
- Conditions
- Kallmann Syndrome
- Keywords
- Kallmann Syndrome, hypogonadotropic hypogonadism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital for Children and Adolescents, FinlandUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Kallmann syndrome
- Age 15 yrs or more
Key exclusion criteria (1 listed)
- Severe mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | – |
Primary outcome
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
1 secondary outcome
epidemiology
Time frame: by 2012 (anticipated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taneli J Raivio, MD PhD study director
Hospital for Children and Adolescents, Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below) in people with Kallmann Syndrome, run by Hospital for Children and Adolescents, Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2008.