Hyperprolactinemia and Adrenal Steroidogenesis

Terminated

• Conditions: Hyperprolactinemia

• Registration Number: NCT04146389
• Lead Sponsor: Insel Gruppe AG, 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.

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-31
• Study Start: 2021-06-24
• Status Verified: 2023-11
• Primary Completion: 2023-11-06
• Study Completion: 2023-11-06
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital; 🇨🇭 Bern, Switzerland