Hyperprolactinemia and Adrenal Steroidogenesis

Hyperprolactinemia Clinical Trial

— Prado  

Official title:

Hyperprolactinemia and Adrenal Steroidogenesis: is There a Link?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04146389
• Other study ID #: Prado
• Status: Terminated
• Start date: June 24, 2021
• Est. completion date: November 6, 2023

Study information

• Verified date: November 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 6, 2023
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperprolactinemia

Locations

Country	Name	City	State
Switzerland	Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Covariation of plasma prolactin and plasma dehydroepiandrosterone	Covariation of plasma prolactin and plasma dehydroepiandrosterone over time	From pre-treatment till 5 weeks of treatment
Secondary	Change in the plasma steroid profile	Change in the plasma steroid profile over time	From pre-treatment till 5 weeks of treatment
Secondary	Change in plasma prolactin levels	Change in plasma prolactin levels over time	From pre-treatment till 5 weeks of treatment
Secondary	Change in the urine steroid profile	Change in the urine steroid profile over time	From pre-treatment till 5 weeks of treatment
Secondary	Covariation of urinary adrenal steroids	Covariation of urinary adrenal steroids over time	From pre-treatment till 5 weeks of treatment