Clinical trial NCT04146389: Hyperprolactinemia and Adrenal Steroidogenesis
Official title: Hyperprolactinemia and Adrenal Steroidogenesis: is There a Link?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hyperprolactinemia
Keywords: adrenal steroidogenesis
doping
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Covariation of plasma prolactin and plasma dehydroepiandrosterone
timeFrame: From pre-treatment till 5 weeks of treatment
Secondary outcomes:
measure: Change in the plasma steroid profile
timeFrame: From pre-treatment till 5 weeks of treatment
measure: Change in plasma prolactin levels
timeFrame: From pre-treatment till 5 weeks of treatment
measure: Change in the urine steroid profile
timeFrame: From pre-treatment till 5 weeks of treatment
measure: Covariation of urinary adrenal steroids
timeFrame: From pre-treatment till 5 weeks of treatment
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Study officials:
affiliation: Inselspital, Bern University Hospital, University of Bern
name: Lia Bally, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: