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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04146389
Other study ID # Prado
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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