RetrospectiveNCT04414085
The Clinical Significance of Biochemical 11 Deoxycortisol Levels
An observational study of Retrospective, run by Assaf Harofeh MC at 1 site in Israel.
Trial summary
data from charts regarding clinical characteristics and androgens levels from first to last visit were collected Read more about this study
- Who is it for?
- Ages 10 to 18 years, women only
- Conditions the study is for
- Retrospective
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Oct 2015to 15 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: All referred to gynecology endocrinology adolescents clinic who underwent an ACTH stimulation test
Who may be able to join
- age 10-18 years referred to gynecology endocrinology adolescents clinic
Who cannot join
- no data available in chart no blood work available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Retrospective
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of hyperandrogenism signs (1 to 3 categorized)
hirsuitism, acne, menses, each marked as 0 or 1 (none or present)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 Oct 2015
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetrospectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf Harofeh MC
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- galia barash, md, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414085
- Sponsor's protocol ID
- 0183-15-ASF
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Biochemical Polymorphism in the 11 Deoxycortisol Levels Before and After Stimulation With Adrenocorticotrofin
- ClinicalTrials.gov ID
- NCT04414085
- Acronym / sponsor ID
- 0183-15-ASF
- Conditions
- Retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assaf Harofeh MCOther government
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
data from charts regarding clinical characteristics and androgens levels from first to last visit were collected
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All referred to gynecology endocrinology adolescents clinic who underwent an ACTH stimulation test
Key inclusion criteria (1 listed)
- age 10-18 years referred to gynecology endocrinology adolescents clinic
Key exclusion criteria (1 listed)
- no data available in chart no blood work available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of hyperandrogenism signs (1 to 3 categorized)
Time frame: 3 years
hirsuitism, acne, menses, each marked as 0 or 1 (none or present)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
galia barash, md principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retrospective, run by Assaf Harofeh MC at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of hyperandrogenism signs (1 to 3 categorized) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.