Hyperprolactinemia and Adrenal Steroidogenesis

Hyperprolactinemia and Adrenal Steroidogenesis: is There a Link?

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04146389

Acronym

Prado

Enrollment

Registered

2019-10-31

Start date

2021-06-24

Completion date

2023-11-06

Last updated

2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperprolactinemia

Keywords

adrenal steroidogenesis, doping

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Covariation of plasma prolactin and plasma dehydroepiandrosterone	From pre-treatment till 5 weeks of treatment	Covariation of plasma prolactin and plasma dehydroepiandrosterone over time

Secondary

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

Countries

Switzerland

Outcome results