The Clinical Significance of Biochemical 11 Deoxycortisol Levels

May 29, 2020 updated by: Assaf Harofeh MC

The Clinical Significance of Biochemical Polymorphism in the 11 Deoxycortisol Levels Before and After Stimulation With Adrenocorticotrofin

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All referred to gynecology endocrinology adolescents clinic who underwent an ACTH stimulation test

Description

Inclusion Criteria:

age 10-18 years referred to gynecology endocrinology adolescents clinic

Exclusion Criteria:

no data available in chart no blood work available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of hyperandrogenism signs (1 to 3 categorized)
Time Frame: 3 years
hirsuitism, acne, menses, each marked as 0 or 1 (none or present)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf Harofeh MC

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2015

Primary Completion (Actual)

May 15, 2020

Study Completion (Actual)

May 15, 2020

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 0183-15-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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