Androgen DeficiencyEffAndonOSNCT07168265
The Effects of Androgen Replacement Therapy on Tear Osmolarity and Ocular Surface Parameters in Androgen Deficiency
A study testing androgen replacement therapy in people with Androgen Deficiency and Ocular Surface Disease, run by Neon Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: To evaluate tear osmolarity and ocular surface findings in men with androgen deficiency (AD) and assess changes after androgen replacement therapy (ART). Design: A prospective interventional study. Participants and Methods Right eyes of 77 male participants were evaluated in this study. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Androgen Deficiency, Ocular Surface Disease, Tear Osmolarity
- What is being tested?
- androgen replacement therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 15 Jun 2025
- Phase
- Interventional
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Androgen deficiency
Who cannot join
- having any ocular disease, history of surgery, drop use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University
Samsun, Atakum, 55139
About this study
Objective: To evaluate tear osmolarity and ocular surface findings in men with androgen deficiency (AD) and assess changes after androgen replacement therapy (ART).
Design: A prospective interventional study. Participants and Methods Right eyes of 77 male participants were evaluated in this study. Serum total testosterone level were measured, and participants were categorized as AD group (testicular hypofunction, n=37, testosterone level <231 ng/dL) and control group (healthy controls, n=40, testosterone level >346 ng/dL). The parameters including Aging Male Symptoms Scale(AMS), OSDI scores, Meibomian Gland Dysfunction- Grading System(MGD-GS) scores, corneal staining, tear break-up time(TBUT), Schirmer I/II tests, tear osmolarity, the depth (TMD), the height (TMH) and the area (TMA) of inferior tear meniscus were investigated. AD group received intramuscular testosterone every two weeks.
Main Outcome Measures: The changes in the ocular surface parameters were investigated during the ART while comparing the values of these parameters between the AD and control groups at baseline, 6th and 18th weeks of the treatment.
- Conditions
- Androgen Deficiency, Ocular Surface Disease, Tear Osmolarity
- Being tested
- androgen replacement therapy
- Keywords
- androgen deficiency, ocular surface, tear osmolarity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
androgen replacement therapyDrug
intramuscular testosterone
| Study group | Role | What they receive |
|---|---|---|
| testosterone | Other | Not described Receives: Drug: androgen replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Osmolarity in mOsm/L
Tear osmolarity was measured by TearLab device in patients. The changes in the tear osmolarity were investigated during the ART while comparing the values of these parameters between the AD and control groups at baseline, 6th and 18th weeks of the treatment.
Measured: 5 months
Schirmer Test in mm
Schirmer Test is applied by Schirmer tear paper after anesthesic drop administration into the eye.
Measured: 5 months
Tear break-up time (TBUT) in sec
TBUT is measured by ophthalmologist after application of fluorecein dye.
Measured: 5 months
MGD-GS score in number
MGD-GS score was performed by ophthalmolgist using biomicroscopy
Measured: 5 months
Questionary Scoring in number
AMS and OSDI scoring charts were completed by the participants.
Measured: 5 months
Optical Coherence Tomography findings: TMH, TMA, and TMD in microns
Tear meniscus height (TMH), area (TMA), and depth (TMD) were measured by Optical coherence tomography in each participants.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Jan 2020
- Primary completion30 Aug 2020
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168265
- Sponsor's protocol ID
- OMU KAEK 2021/557
- Other IDs
- OMU
- Acronym
- EffAndonOS
- Status last verified
- Sep 2025
- First submitted
- 21 Jun 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Androgen Replacement Therapy on Tear Osmolarity and Ocular Surface Parameters in Androgen Deficiency
- ClinicalTrials.gov ID
- NCT07168265
- Acronym / sponsor ID
- EffAndonOS / OMU KAEK 2021/557
- Conditions
- Androgen Deficiency, Ocular Surface Disease, Tear Osmolarity
- Keywords
- androgen deficiency, ocular surface, tear osmolarity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Neon HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 11 Sep 2025 (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.
Objective: To evaluate tear osmolarity and ocular surface findings in men with androgen deficiency (AD) and assess changes after androgen replacement therapy (ART).
Design: A prospective interventional study. Participants and Methods Right eyes of 77 male participants were evaluated in this study. Serum total testosterone level were measured, and participants were categorized as AD group (testicular hypofunction, n=37, testosterone level <231 ng/dL) and control group (healthy controls, n=40, testosterone level >346 ng/dL). The parameters including Aging Male Symptoms Scale(AMS), OSDI scores, Meibomian Gland Dysfunction- Grading System(MGD-GS) scores, corneal staining, tear break-up time(TBUT), Schirmer I/II tests, tear osmolarity, the depth (TMD), the height (TMH) and the area (TMA) of inferior tear meniscus were investigated. AD group received intramuscular testosterone every two weeks.
Main Outcome Measures: The changes in the ocular surface parameters were investigated during the ART while comparing the values of these parameters between the AD and control groups at baseline, 6th and 18th weeks of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| testosterone | Other | Drug: androgen replacement therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Androgen deficiency
Key exclusion criteria (1 listed)
- having any ocular disease, history of surgery, drop use
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 |
|---|---|---|
| androgen replacement therapyintramuscular testosterone | Drug | testosterone |
Primary outcome
Tear Osmolarity in mOsm/L
Time frame: 5 months
Tear osmolarity was measured by TearLab device in patients. The changes in the tear osmolarity were investigated during the ART while comparing the values of these parameters between the AD and control groups at baseline, 6th and 18th weeks of the treatment.
Schirmer Test in mm
Time frame: 5 months
Schirmer Test is applied by Schirmer tear paper after anesthesic drop administration into the eye.
Tear break-up time (TBUT) in sec
Time frame: 5 months
TBUT is measured by ophthalmologist after application of fluorecein dye.
MGD-GS score in number
Time frame: 5 months
MGD-GS score was performed by ophthalmolgist using biomicroscopy
Questionary Scoring in number
Time frame: 5 months
AMS and OSDI scoring charts were completed by the participants.
Optical Coherence Tomography findings: TMH, TMA, and TMD in microns
Time frame: 5 months
Tear meniscus height (TMH), area (TMA), and depth (TMD) were measured by Optical coherence tomography in each participants.
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 11 Sep 2025.
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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.
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?
A study testing androgen replacement therapy in people with Androgen Deficiency and Ocular Surface Disease, 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 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 11 Sep 2025. 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?
Tear Osmolarity in mOsm/L (time frame: 5 months). The study lists 6 primary outcomes in all. 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 11 Sep 2025.