Hyperprolactinemia and Adrenal Steroidogenesis (Prado)

November 29, 2023 updated by: Insel Gruppe AG, University Hospital Bern

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

Inclusion Criteria:

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

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 informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From pre-treatment till 5 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the plasma steroid profile
Time Frame: From pre-treatment till 5 weeks of treatment
Change in the plasma steroid profile over time
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 plasma prolactin levels over time
From pre-treatment till 5 weeks of treatment
Change in the urine steroid profile
Time Frame: From pre-treatment till 5 weeks of treatment
Change in the urine steroid profile over time
From pre-treatment till 5 weeks of treatment
Covariation of urinary adrenal steroids
Time Frame: From pre-treatment till 5 weeks of treatment
Covariation of urinary adrenal steroids over time
From pre-treatment till 5 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

  • Principal Investigator: Lia Bally, MD PhD, Inselspital, Bern University Hospital, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2021

Primary Completion (Actual)

November 6, 2023

Study Completion (Actual)

November 6, 2023

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prado

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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