Delayed PubertyNCT02034487
Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment
An observational study of Delayed Puberty, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
To evaluate the phenotype and biochemical characteristics of boys referred for delayed puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate the diagnostic criteria and the effect of testosterone treatment. Read more about this study
- Who is it for?
- Ages 13 to 20 years, men only
- Conditions the study is for
- Delayed Puberty
- What is being tested?
- retrospective data collection
- How many people
- 451 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 1990to Oct 2013
- Phase
- Observational
- 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 13 to 20 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: The study population consisted of boys who were referred to be evaluated for delayed puberty at the Department of Growth and Reproduction between January 1990 and February 2013.
Who may be able to join
- All boys identified in the period from January 1990 to February 2013
Who cannot join
- Misclassified (other diagnoses)
- Insufficient data
- Lost to follow up
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, 2100
About this study
Official title: Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment - Retrospective Experience From a Single Tertiary Referral Centre 1990-2013
To evaluate the phenotype and biochemical characteristics of boys referred for delayed puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate the diagnostic criteria and the effect of testosterone treatment.
Read the detailed description
Delayed Puberty in Boys; Clinical and biochemical characteristics and effect of testosterone treatment, is a retrospective study in a large case series of Danish boys with delayed puberty.
All boys were referred to the Department of Growth and Reproduction to be evaluated for delayed puberty.
Medical history: Birth length, birth weight, gestational age at birth, medical history (including cryptorchidism and hypospadias), family history of delayed puberty in mother, father and possible siblings.
Physical examination: Pubertal staging according to Tanners classification of boys, genitalia development (G1-G5), pubic hair development (PH1-PH6), axillary hair (yes/no), axillary sweat (yes/no), gynecomastia (yes/no), micropenis (yes/no), height, mother height, father height, target height, weight, BMI, bone age and predicted adult height.
Blood sampling for measurement of hormone levels: Follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, anti-mullerian hormone, sex hormone-binding globulin, testosterone, dehydroepiandrosterone-sulfate, androstenedione, inhibin A, inhibin B, growth hormone, insulin like growth factor-1 and insulin like growth factor binding protein-3.
Gonadotropin-releasing hormone stimulation test for measurement of peak FSH and peak LH.
Retrospective DNA analysis looking for common polymorphisms.
If testosterone treatment were initiated, route of administration, dose and duration of treatment were registered.
- Conditions
- Delayed Puberty
- Being tested
- retrospective data collection
- Keywords
- Delayed Puberty, Boys, Hormones, Polymorphism, Genetic
- Medical subject headings
- Puberty, Delayed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective data collectionOther
| Study group | Role | What they receive |
|---|---|---|
| Boys with delayed puberty | Boys with no signs of puberty by an age that is -2 standard deviation below the population mean. Receives: Other: retrospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at diagnosis in boys with delayed puberty.
We will evaluate the mean age at diagnosis as well as the age distribution of newly diagnosed boys. These data are compared to age at onset and progression of normal puberty in contemporary healthy Danish boys.
Measured: At first evaluation
Secondary outcomes (1)
Selected secondary outcomes include clinical, auxological and biochemical parameters and association to specific genetic polymorphisms
Specifically, genital stage, pubic hair stage, axillary hair, axillary sweat, gynecomastia, micropenis, height, mother height, father height, target height, weight, BMI, bone age and predicted adult height. We will evaluate serum levels of follicle stimulating hormone, luteinizing hormone, estradiol, anti-mullerian hormone, sex hormone-binding globulin, testosterone, dehydroepiandrosterone-sulfate, androstenedione, inhibin A, inhibin B, growth hormone, insulin like growth factor-1 and insulin like growth factor binding protein-3. We will evaluate the effect of candidate polymorphisms suspected to affect pubertal timing, e.g. FSHR, FSHB, FGF23, KISS1, NeurokininB, GnRH, GnRH-R, LH, LH-R, GHRd3.
Measured: At first evaluation and during first 12 months of observation / treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 1990
- Primary completionFeb 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed PubertyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Juul, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Anders Juul, PhD, DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034487
- Sponsor's protocol ID
- KF01328087
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 13 Jan 2014
- Results posted
- No
Publications
Lawaetz JG, Hagen CP, Mieritz MG, Blomberg Jensen M, Petersen JH, Juul A. Evaluation of 451 Danish boys with delayed puberty: diagnostic use of a new puberty nomogram and effects of oral testosterone therapy. J Clin Endocrinol Metab. 2015 Apr;100(4):1376-85. doi: 10.1210/jc.2014-3631. Epub 2015 Jan 16.
PubMed 25594861
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment - Retrospective Experience From a Single Tertiary Referral Centre 1990-2013
- ClinicalTrials.gov ID
- NCT02034487
- Acronym / sponsor ID
- KF01328087
- Conditions
- Delayed Puberty
- Keywords
- Delayed Puberty, Boys, Hormones, Polymorphism, Genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 1990
- Primary completion
- Feb 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Jan 2014 (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.
To evaluate the phenotype and biochemical characteristics of boys referred for delayed puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate the diagnostic criteria and the effect of testosterone treatment.
Detailed description
Delayed Puberty in Boys; Clinical and biochemical characteristics and effect of testosterone treatment, is a retrospective study in a large case series of Danish boys with delayed puberty.
All boys were referred to the Department of Growth and Reproduction to be evaluated for delayed puberty.
Medical history: Birth length, birth weight, gestational age at birth, medical history (including cryptorchidism and hypospadias), family history of delayed puberty in mother, father and possible siblings.
Physical examination: Pubertal staging according to Tanners classification of boys, genitalia development (G1-G5), pubic hair development (PH1-PH6), axillary hair (yes/no), axillary sweat (yes/no), gynecomastia (yes/no), micropenis (yes/no), height, mother height, father height, target height, weight, BMI, bone age and predicted adult height.
Blood sampling for measurement of hormone levels: Follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, anti-mullerian hormone, sex hormone-binding globulin, testosterone, dehydroepiandrosterone-sulfate, androstenedione, inhibin A, inhibin B, growth hormone, insulin like growth factor-1 and insulin like growth factor binding protein-3.
Gonadotropin-releasing hormone stimulation test for measurement of peak FSH and peak LH.
Retrospective DNA analysis looking for common polymorphisms.
If testosterone treatment were initiated, route of administration, dose and duration of treatment were registered.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boys with delayed puberty | – | Other: retrospective data collectionBoys with no signs of puberty by an age that is -2 standard deviation below the population mean. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consisted of boys who were referred to be evaluated for delayed puberty at the Department of Growth and Reproduction between January 1990 and February 2013.
Key inclusion criteria (1 listed)
- All boys identified in the period from January 1990 to February 2013
Key exclusion criteria (3 listed)
- Misclassified (other diagnoses)
- Insufficient data
- Lost to follow up
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 |
|---|---|---|
| retrospective data collection | Other | Boys with delayed puberty |
Primary outcome
Age at diagnosis in boys with delayed puberty.
Time frame: At first evaluation
We will evaluate the mean age at diagnosis as well as the age distribution of newly diagnosed boys. These data are compared to age at onset and progression of normal puberty in contemporary healthy Danish boys.
1 secondary outcome
Selected secondary outcomes include clinical, auxological and biochemical parameters and association to specific genetic polymorphisms
Time frame: At first evaluation and during first 12 months of observation / treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- Derived from this study: PubMed 25594861Lawaetz JG, Hagen CP, Mieritz MG, Blomberg Jensen M, Petersen JH, Juul A. Evaluation of 451 Danish boys with delayed puberty: diagnostic use of a new puberty nomogram and effects of oral testosterone therapy. J Clin Endocrinol Metab. 2015 Apr;100(4):1376-85. doi: 10.1210/jc.2014-3631. Epub 2015 Jan 16.
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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.
Anders Juul, PhD, DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed Puberty, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jan 2014. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Age at diagnosis in boys with delayed puberty. (time frame: At first evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02034487, which also lists 1 linked publication.
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 13 Jan 2014.