HyperprolactinemiaPROSANCT05033119
PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
An observational study of Hyperprolactinemia and Puberty Disorders, run by Ulla Schierup Nielsen at 3 sites in Denmark.
Trial summary
The objectives of this study are: 1. To determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications 2. To determine the associations between serum-prolactin and sex hormones / metabolic biomarkers/ clinical symptoms in this population. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Hyperprolactinemia, Puberty Disorders, Metabolic Syndrome
- How many people
- 90 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Nov 2021to 31 Dec 2024
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All outpatients aged 7-18 years receiving treatment with antipsychotics at the Department of Child and Adolescent Psychiatry, Aalborg University Hospital, the Department of Child and Adolescent Psychiatry, Aarhus University Hospital and at the Child and Adolescent Mental Health Center, Copenhagen University Hospital, Capital Region will be invited to participate in the study.
Who may be able to join
- • In daily treatment with antipsychotic medication belonging to Anatomical Therapeutic Chemical (ATC) group N05A (except N05AN lithium) for a minimum duration of 3 months prior to inclusion
Who cannot join
- Eating Disorder
- Medical treatment to change sex
- Pregnancy or lactation
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Research Unit for Child and Adolescent Psychiatry, Aalborg University Hospital, Denmark
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8200
Child and Adolescent Mental Health Center Capital Region, Denmark
Copenhagen
About this study
The objectives of this study are:
- To determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications
- To determine the associations between serum-prolactin and sex hormones / metabolic biomarkers/ clinical symptoms in this population. If clinically relevant associations are found: To determine a potentially existing "no harm" serum-prolactin threshold
- To determine associations between previous cumulative prolactin-exposure and current pubertal development / growth
- Conditions
- Hyperprolactinemia, Puberty Disorders, Metabolic Syndrome, Growth Disorders, Antipsychotics and Neuroleptics Toxicity
- Medical subject headings
- Hyperprolactinemia, Metabolic Syndrome, Growth Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hyperprolactinemia
Measured: 2 years
Secondary outcomes (2)
associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms
Measured: 2 years
associations between previous prolactin-exposure and current pubertal development / growth
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperprolactinemiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulla Schierup Nielsen
- Sponsor type
- University, hospital or other
- Collaborators
- North Denmark Region, Central Denmark Region, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Responsible party
- Sponsor-investigator, Ulla Schierup Nielsen, Aalborg University Hospital
- Investigators
- Ulla S Nielsen, Study director, Research Unit for Child and Adolescent Psychiatry, Aalborg,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033119
- Sponsor's protocol ID
- N-20210029
- Acronym
- PROSA
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
- ClinicalTrials.gov ID
- NCT05033119
- Acronym / sponsor ID
- PROSA / N-20210029
- Conditions
- Hyperprolactinemia, Puberty Disorders, Metabolic Syndrome, Growth Disorders, Antipsychotics and Neuroleptics Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ulla Schierup NielsenUniversity, hospital or other
- Collaborators
- North Denmark Region, Central Denmark Region, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Sep 2021 (actual)
- 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.
The objectives of this study are:
- To determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications
- To determine the associations between serum-prolactin and sex hormones / metabolic biomarkers/ clinical symptoms in this population. If clinically relevant associations are found: To determine a potentially existing "no harm" serum-prolactin threshold
- To determine associations between previous cumulative prolactin-exposure and current pubertal development / growth
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All outpatients aged 7-18 years receiving treatment with antipsychotics at the Department of Child and Adolescent Psychiatry, Aalborg University Hospital, the Department of Child and Adolescent Psychiatry, Aarhus University Hospital and at the Child and Adolescent Mental Health Center, Copenhagen University Hospital, Capital Region will be invited to participate in the study.
Key inclusion criteria (1 listed)
- • In daily treatment with antipsychotic medication belonging to Anatomical Therapeutic Chemical (ATC) group N05A (except N05AN lithium) for a minimum duration of 3 months prior to inclusion
Key exclusion criteria (3 listed)
- Eating Disorder
- Medical treatment to change sex
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of hyperprolactinemia
Time frame: 2 years
2 secondary outcomes
associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms
Time frame: 2 years
associations between previous prolactin-exposure and current pubertal development / growth
Time frame: 2 years
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 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Ulla S Nielsen study director
Research Unit for Child and Adolescent Psychiatry, Aalborg,
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperprolactinemia and Puberty Disorders, run by Ulla Schierup Nielsen at 3 sites 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Prevalence of hyperprolactinemia (time frame: 2 years). 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 30 Apr 2026.