Study Stopped
Preliminary analyses of the samples provide no indication for a clinically relevant relationship between hyperprolactinemia and stimulation of adrenal steroidogenesis.
Hyperprolactinemia and Adrenal Steroidogenesis
Prado
1 other identifier
observational
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedStudy Start
First participant enrolled
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2023
CompletedDecember 6, 2023
November 1, 2023
2.4 years
October 28, 2019
November 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in the plasma steroid profile
From pre-treatment till 5 weeks of treatment
Change in plasma prolactin levels
From pre-treatment till 5 weeks of treatment
Change in the urine steroid profile
From pre-treatment till 5 weeks of treatment
Covariation of urinary adrenal steroids
From pre-treatment till 5 weeks of treatment
Eligibility Criteria
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.
You may qualify if:
- Aged 18 years or older
- Female and pre-menopausal
- Serum prolactin \> 150 ng/ml
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, 3010, Switzerland
Biospecimen
Blood and urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lia Bally, MD PhD
Inselspital, Bern University Hospital, University of Bern
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
October 31, 2019
Study Start
June 24, 2021
Primary Completion
November 6, 2023
Study Completion
November 6, 2023
Last Updated
December 6, 2023
Record last verified: 2023-11