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The Clinical Significance of Biochemical 11 Deoxycortisol Levels

Sponsor
Assaf Harofeh MC (Other)
Overall Status
Completed
CT.gov ID
NCT04414085
Collaborator
(none)
120
Enrollment
1
Location
55
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

data from charts regarding clinical characteristics and androgens levels from first to last visit were collected

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    data from charts regarding clinical characteristics and androgens levels from first to last visit were collected Female patients only ages 10-18 years who were referred to the combined gynecology endocrinology adolescents clinic

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Clinical Significance of Biochemical Polymorphism in the 11 Deoxycortisol Levels Before and After Stimulation With Adrenocorticotrofin
    Actual Study Start Date :
    Oct 15, 2015
    Actual Primary Completion Date :
    May 15, 2020
    Actual Study Completion Date :
    May 15, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Presence of hyperandrogenism signs (1 to 3 categorized) [3 years]

      hirsuitism, acne, menses, each marked as 0 or 1 (none or present)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 18 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    age 10-18 years referred to gynecology endocrinology adolescents clinic

    Exclusion Criteria:

    no data available in chart no blood work available

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assaf Harofeh Medical Center Zerifin Israel 70300

    Sponsors and Collaborators

    • Assaf Harofeh MC

    Investigators

    • Principal Investigator: galia barash, md, Assaf-Harofeh Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assaf Harofeh MC, Galia Askapa, Assaf-Harofeh Medical Center
    ClinicalTrials.gov Identifier:
    NCT04414085
    Other Study ID Numbers:
    • 0183-15-ASF
    First Posted:
    Jun 4, 2020
    Last Update Posted:
    Jun 4, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 4, 2020