HyperprolactinemiaPradoNCT04146389
Hyperprolactinemia and Adrenal Steroidogenesis
An observational study of Hyperprolactinemia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study is to explore the effects of prolactin on adrenal steroid profiles in patients with hyperprolactinemia due to prolactinomas before and after initialisation of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hyperprolactinemia
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jun 2021to 6 Nov 2023
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study will involve up to 17 pre-menopausal female individuals with hyperprolactinemia due to prolactinomas, who will undergo treatment at the University Hospital Bern.
Who may be able to join
- Aged 18 years or older
- Female and pre-menopausal
- Serum prolactin > 150 ng/ml
Who cannot join
- Corticotropic and/or thyreotropic insufficiency
- Pregnancy, planned pregnancy or breastfeeding
- Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Incapacity to give informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, 3010
About this study
Official title: Hyperprolactinemia and Adrenal Steroidogenesis: is There a Link?
The purpose of this study is to explore the effects of prolactin on adrenal steroid profiles in patients with hyperprolactinemia due to prolactinomas before and after initialisation of treatment.
Read the detailed description
Prolactin is known to influence many biological processes. One potential target is the adrenal gland, where prolactin may stimulate the production of adrenal steroid hormones. Conditions of increased prolactin production(hyperprolactinemia) could, therefore, increase concentrations of adrenal steroids. One of the potential implications would be false doping accusations of athletes engaging in elite sports.
This interaction between prolactin and adrenal steroidogenesis, however, remains poorly understood, and the available research findings are conflicting.
The investigators, therefore, seek to explore the relationship between prolactin and adrenal steroidogenesis by monitoring prolactin levels and blood and urinary steroid profiles of patients with hyperprolactinemia due to prolactinomas before and after treatment initialisation.
- Conditions
- Hyperprolactinemia
- Keywords
- adrenal steroidogenesis, doping
- Medical subject headings
- Hyperprolactinemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Covariation of plasma prolactin and plasma dehydroepiandrosterone
Covariation of plasma prolactin and plasma dehydroepiandrosterone over time
Measured: From pre-treatment till 5 weeks of treatment
Secondary outcomes (4)
Change in the plasma steroid profile
Change in the plasma steroid profile over time
Measured: From pre-treatment till 5 weeks of treatment
Change in plasma prolactin levels
Change in plasma prolactin levels over time
Measured: From pre-treatment till 5 weeks of treatment
Change in the urine steroid profile
Change in the urine steroid profile over time
Measured: From pre-treatment till 5 weeks of treatment
Covariation of urinary adrenal steroids
Covariation of urinary adrenal steroids over time
Measured: From pre-treatment till 5 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start24 Jun 2021
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Why it stopped: Preliminary analyses of the samples provide no indication for a clinically relevant relationship between hyperprolactinemia and stimulation of adrenal steroidogenesis.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lia Bally, MD PhD, Principal investigator, Inselspital, Bern University Hospital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146389
- Sponsor's protocol ID
- Prado
- Acronym
- Prado
- Status last verified
- Nov 2023
- First submitted
- 28 Oct 2019
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperprolactinemia and Adrenal Steroidogenesis: is There a Link?
- ClinicalTrials.gov ID
- NCT04146389
- Acronym / sponsor ID
- Prado / Prado
- Conditions
- Hyperprolactinemia
- Keywords
- adrenal steroidogenesis, doping
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Preliminary analyses of the samples provide no indication for a clinically relevant relationship between hyperprolactinemia and stimulation of adrenal steroidogenesis.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 31 Oct 2019 (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 purpose of this study is to explore the effects of prolactin on adrenal steroid profiles in patients with hyperprolactinemia due to prolactinomas before and after initialisation of treatment.
Detailed description
Prolactin is known to influence many biological processes. One potential target is the adrenal gland, where prolactin may stimulate the production of adrenal steroid hormones. Conditions of increased prolactin production(hyperprolactinemia) could, therefore, increase concentrations of adrenal steroids. One of the potential implications would be false doping accusations of athletes engaging in elite sports.
This interaction between prolactin and adrenal steroidogenesis, however, remains poorly understood, and the available research findings are conflicting.
The investigators, therefore, seek to explore the relationship between prolactin and adrenal steroidogenesis by monitoring prolactin levels and blood and urinary steroid profiles of patients with hyperprolactinemia due to prolactinomas before and after treatment initialisation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will involve up to 17 pre-menopausal female individuals with hyperprolactinemia due to prolactinomas, who will undergo treatment at the University Hospital Bern.
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Female and pre-menopausal
- Serum prolactin > 150 ng/ml
Key exclusion criteria (4 listed)
- Corticotropic and/or thyreotropic insufficiency
- Pregnancy, planned pregnancy or breastfeeding
- Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Incapacity to give informed consent
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
Covariation of plasma prolactin and plasma dehydroepiandrosterone
Time frame: From pre-treatment till 5 weeks of treatment
Covariation of plasma prolactin and plasma dehydroepiandrosterone over time
4 secondary outcomes
Change in the plasma steroid profile
Time frame: From pre-treatment till 5 weeks of treatment
Change in plasma prolactin levels
Time frame: From pre-treatment till 5 weeks of treatment
Change in the urine steroid profile
Time frame: From pre-treatment till 5 weeks of treatment
Covariation of urinary adrenal steroids
Time frame: From pre-treatment till 5 weeks of treatment
Results and safety
The study was stopped early (reason given: Preliminary analyses of the samples provide no indication for a clinically relevant relationship between hyperprolactinemia and stimulation of adrenal steroidogenesis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
Lia Bally, MD PhD principal investigator
Inselspital, Bern University Hospital, University of Bern
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 Hyperprolactinemia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Dec 2023. 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 Switzerland. 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 was stopped early (reason given: Preliminary analyses of the samples provide no indication for a clinically relevant relationship between hyperprolactinemia and stimulation of adrenal steroidogenesis.). 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?
Covariation of plasma prolactin and plasma dehydroepiandrosterone (time frame: From pre-treatment till 5 weeks of treatment). 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 6 Dec 2023.