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TerminatedNCT04146389PradoUpdated Dec 6, 2023

Hyperprolactinemia and Adrenal Steroidogenesis

An observational study in Hyperprolactinemia, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Why this study was terminated
Preliminary analyses of the samples provide no indication for a clinically relevant relationship between hyperprolactinemia and stimulation of adrenal steroidogenesis.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Hyperprolactinemia

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Keywords

  • adrenal steroidogenesis
  • doping
03

In context

Hyperprolactinemia

39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.

This study's enrollment of 5 is below the median of 114 across 16 observational studies indexed under Hyperprolactinemia.

Browse Hyperprolactinemia studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 years or older
  • Female and pre-menopausal
  • Serum prolactin > 150 ng/ml

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Covariation of plasma prolactin and plasma dehydroepiandrosterone

    Covariation of plasma prolactin and plasma dehydroepiandrosterone over time

    Time frame: From pre-treatment till 5 weeks of treatment

Secondary outcomes

  1. Change in the plasma steroid profile

    Change in the plasma steroid profile over time

    Time frame: From pre-treatment till 5 weeks of treatment

  2. Change in plasma prolactin levels

    Change in plasma prolactin levels over time

    Time frame: From pre-treatment till 5 weeks of treatment

  3. Change in the urine steroid profile

    Change in the urine steroid profile over time

    Time frame: From pre-treatment till 5 weeks of treatment

  4. Covariation of urinary adrenal steroids

    Covariation of urinary adrenal steroids over time

    Time frame: From pre-treatment till 5 weeks of treatment

07

Study locations

1 site
  • Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
    Bern, 3010, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04146389
Responsible party
Sponsor
First posted
Oct 31, 2019
Start date
Jun 24, 2021
Primary completion
Nov 6, 2023
Completion
Nov 6, 2023
Last update
Dec 6, 2023

Study contacts

Lia Bally, MD PhD
principal investigator · Inselspital, Bern University Hospital, University of Bern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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