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Prado: Hyperprolactinemia and Adrenal Steroidogenesis

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT04146389
Collaborator
(none)
17
Enrollment
1
Location
11.2
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    17 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Hyperprolactinemia and Adrenal Steroidogenesis: is There a Link?
    Actual Study Start Date :
    Jun 24, 2021
    Anticipated Primary Completion Date :
    May 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change in the plasma steroid profile [From pre-treatment till 5 weeks of treatment]

      Change in the plasma steroid profile over time

    2. Change in plasma prolactin levels [From pre-treatment till 5 weeks of treatment]

      Change in plasma prolactin levels over time

    3. Change in the urine steroid profile [From pre-treatment till 5 weeks of treatment]

      Change in the urine steroid profile over time

    4. Covariation of urinary adrenal steroids [From pre-treatment till 5 weeks of treatment]

      Covariation of urinary adrenal steroids over time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital Bern Switzerland 3010

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne

    Investigators

    • Principal Investigator: Lia Bally, MD PhD, Inselspital, Bern University Hospital, University of Bern

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Inselspital, Berne
    ClinicalTrials.gov Identifier:
    NCT04146389
    Other Study ID Numbers:
    • Prado
    First Posted:
    Oct 31, 2019
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital Inselspital, Berne
    adrenal steroidogenesis
    doping
    Additional relevant MeSH terms:
    Hyperprolactinemia

    Study Results

    No Results Posted as of Aug 16, 2021