Hyperprolactinemia Clinical Trial
— PradoOfficial title:
Hyperprolactinemia and Adrenal Steroidogenesis: is There a Link?
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 |
Verified date | November 2023 |
Source | Insel Gruppe AG, University Hospital Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
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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