Effects of the External Testosteron Intake Over the Choroids of the Patients With Androgen DeficiencyNCT04342247
Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study
An observational study of Effects of the External Testosteron Intake Over the Choroids of the Patients With Androgen Deficiency, run by Neon Hospital at 1 site in Turkey (Türkiye).
Trial summary
According to the results Ciloğlu et al., CSC is related to elevated total testosterone levels. Testosterone may play a role in predisposing males to CSC. Thus, we aimed to investigate the possible effect of external testosteron intake over choroidal parameters; such as choroidal thickness, choroidal vascularity index… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of the External Testosteron Intake Over the Choroids of the Patients With Androgen Deficiency
- What is being tested?
- external testosteron
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Mar 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: randomly selected subjects aged between 30 and 800
Who may be able to join
- for androgen deficient group: no other ocular and systemic disease except androgen deficiency. no history of ocular surgery or disease no medicine use for healthy controls :no other ocular and systemic disease. no history of ocular surgery or disease no medicine use, no smoking or any tobocco use
- Exclusion Criteria:having any ocular and systemic disease. history of ocular surgery or disease,medicine use, smoking or any tobocco use
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical
According to the results Ciloğlu et al., CSC is related to elevated total testosterone levels. Testosterone may play a role in predisposing males to CSC. Thus, we aimed to investigate the possible effect of external testosteron intake over choroidal parameters; such as choroidal thickness, choroidal vascularity index, choroidal stromal ve luminal areas,ect.
Read the detailed description
In the study, we have two group: First group consists of patients with testosteron deficiency and there are sex and age-matched healthy control subjects in the second group. We will measure the parameters of both groups at baseline. And first month and 3rd month we will remeasure the values of the parameters by enhance depth optical coherence tomography. The results will be compared between the groups.
- Being tested
- external testosteron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external testosteronDrug
external testosteron
| Study group | Role | What they receive |
|---|---|---|
| androgen deficient | Not described Receives: Drug: external testosteron | |
| healthy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study
to obtain the measurements of the choroids
Measured: 2019 and 20120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of the External Testosteron Intake Over the Choroids of the Patients With Androgen DeficiencyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan YETER, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342247
- Sponsor's protocol ID
- 2019/568
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical
- ClinicalTrials.gov ID
- NCT04342247
- Acronym / sponsor ID
- 2019/568
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Neon HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 10 Apr 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.
According to the results Ciloğlu et al., CSC is related to elevated total testosterone levels. Testosterone may play a role in predisposing males to CSC. Thus, we aimed to investigate the possible effect of external testosteron intake over choroidal parameters; such as choroidal thickness, choroidal vascularity index, choroidal stromal ve luminal areas,ect.
Detailed description
In the study, we have two group: First group consists of patients with testosteron deficiency and there are sex and age-matched healthy control subjects in the second group. We will measure the parameters of both groups at baseline. And first month and 3rd month we will remeasure the values of the parameters by enhance depth optical coherence tomography. The results will be compared between the groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| androgen deficient | – | Drug: external testosteron |
| healthy | – | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- randomly selected subjects aged between 30 and 800
Key inclusion criteria (3 listed)
- for androgen deficient group: no other ocular and systemic disease except androgen deficiency. no history of ocular surgery or disease no medicine use for healthy controls :no other ocular and systemic disease. no history of ocular surgery or disease no medicine use, no smoking or any tobocco use
- Exclusion Criteria:having any ocular and systemic disease. history of ocular surgery or disease,medicine use, smoking or any tobocco use
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external testosteronexternal testosteron | Drug | androgen deficient |
Primary outcome
to evaluate Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study
Time frame: 2019 and 20120
to obtain the measurements of the choroids
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 10 Apr 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Effects of the External Testosteron Intake Over the Choroids of the Patients With Androgen Deficiency, run by Neon Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 0 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 10 Apr 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 Turkey (Türkiye). 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?
to evaluate Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study (time frame: 2019 and 20120). 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 10 Apr 2020.