Erectile DysfunctionSOST-ED: SerumNCT07902362
Investigation of Serum Sclerostin Levels in Patients With Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, observational case-control study aims to investigate the potential role of sclerostin-a molecule associated with cardiovascular pathologies-in the vascular pathogenesis of erectile dysfunction (ED). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- Type of treatment
- Injection or infusion
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 2 Jan 2024
- How long will I take part?
- 1 Day
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male patients aged 18 to 65 years who presented to the Urology Outpatient Clinic of Health Sciences University Bagcilar Training and Research Hospital with complaints of erectile dysfunction, and healthy male volunteers of similar age from the same community.
Inclusion Criteria: Men aged between 20 and 65 years , Presenting with complaints of erectile dysfunction (for the case group), Healthy male volunteers (for the control group) -
Exclusion Criteria: Age over 65 years , History of priapism , Presence of Peyronie's disease , Penile skin diseases (e.g., HPV) , History of penile surgery , History of peripheral vascular disease , History of varicocele , Chronic Obstructive Pulmonary Disease (COPD) , Aortic aneurysm , Diabetes , Hypertension , Non-alcoholic steatohepatitis
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Çam and Sakura City Hospital
Istanbul, Basaksehir, 34480
About this study
This prospective, observational case-control study aims to investigate the potential role of sclerostin-a molecule associated with cardiovascular pathologies-in the vascular pathogenesis of erectile dysfunction (ED). The study compares peripheral venous sclerostin levels between men diagnosed with ED and healthy volunteers. Additionally, it evaluates cavernosal blood sclerostin levels within the ED group to explore localized vascular changes.
Read the detailed description
Erectile dysfunction (ED) is closely related to vascular pathologies and is often considered an early indicator of cardiovascular disease. Sclerostin is a glycoprotein synthesized in vascular smooth muscle cells and has been investigated in relation to atherosclerosis and vascular calcification.
This study includes 50 patients with ED and 47 healthy control subjects. The presence and severity of ED are evaluated using the International Index of Erectile Function-5 (IIEF-5) questionnaire and the Erection Hardness Score (EHS). Psychological status is assessed using the Beck Depression Inventory (BDI).
The primary objective is to determine if there is a significant difference in peripheral serum sclerostin levels between the ED group and the healthy control group. The secondary objective involves the ED group exclusively, where a Combined Intracavernosal Injection and Stimulation Test (using 10 mcg alprostadil) is performed to obtain a cavernosal blood sample. This allows for a comparative analysis between peripheral and cavernosal serum sclerostin levels within the same patients to better understand localized endothelial and vascular dynamics in ED. Sclerostin levels are analyzed using the Enzyme-Linked ImmunoSorbent Assay (ELISA) method.
- Conditions
- Erectile Dysfunction
- Keywords
- Sclerostin, Erectile Dsyfunction, Cardiovascular biomarkers, Vascular disease
- Medical subject headings
- Erectile Dysfunction, Sclerosteosis, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Patients diagnosed with erectile dysfunction who undergo the Combined Intracavernosal Injection and Stimulation Test (KİST) and provide peripheral and cavernosal blood samples. | |
| Control Group | Healthy male volunteers without erectile dysfunction who provide only peripheral venous blood samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Serum Sclerostin Levels
The primary outcome is the difference in peripheral venous serum sclerostin levels between patients with erectile dysfunction and healthy controls, measured via the Enzyme-Linked ImmunoSorbent Assay (ELISA) method in ng/ml.
Measured: Baseline
Secondary outcomes (1)
Cavernosal Serum Sclerostin Levels
Cavernosal blood serum sclerostin levels evaluated exclusively in the erectile dysfunction group following the Combined Intracavernosal Injection and Stimulation Test, measured via ELISA in ng/ml.
Measured: Baseline (15 minutes post-injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start2 Jan 2023
- Primary completion1 Jun 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 97 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ihsan Memmi, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902362
- Sponsor's protocol ID
- 27841764830
- Other IDs
- 2011-KAEK-50/322
- Acronym
- SOST-ED: Serum
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to maintain patient privacy and confidentiality, in accordance with the local ethical committee regulations. Data will only be reported and published in aggregate form.
Publications
Teng IC, Wang JH, Lee CJ, Hou JS, Hsu BG. Serum sclerostin as an independent marker of peripheral artery disease in elderly persons. Int J Clin Exp Pathol. 2018 May 1;11(5):2816-2821. eCollection 2018.
PubMed 31938401Golledge J, Thanigaimani S. Role of Sclerostin in Cardiovascular Disease. Arterioscler Thromb Vasc Biol. 2022 Jul;42(7):e187-e202. doi: 10.1161/ATVBAHA.122.317635. Epub 2022 May 12.
PubMed 35546488He F, Li L, Li PP, Deng Y, Yang YY, Deng YX, Luo HH, Yao XT, Su YX, Gan H, He BC. Cyclooxygenase-2/sclerostin mediates TGF-beta1-induced calcification in vascular smooth muscle cells and rats undergoing renal failure. Aging (Albany NY). 2020 Nov 6;12(21):21220-21235. doi: 10.18632/aging.103827. Epub 2020 Nov 6.
PubMed 33159018Krishna SM, Seto SW, Jose RJ, Li J, Morton SK, Biros E, Wang Y, Nsengiyumva V, Lindeman JH, Loots GG, Rush CM, Craig JM, Golledge J. Wnt Signaling Pathway Inhibitor Sclerostin Inhibits Angiotensin II-Induced Aortic Aneurysm and Atherosclerosis. Arterioscler Thromb Vasc Biol. 2017 Mar;37(3):553-566. doi: 10.1161/ATVBAHA.116.308723. Epub 2016 Dec 22.
PubMed 28062506van Bezooijen RL, Deruiter MC, Vilain N, Monteiro RM, Visser A, van der Wee-Pals L, van Munsteren CJ, Hogendoorn PC, Aguet M, Mummery CL, Papapoulos SE, Ten Dijke P, Lowik CW. SOST expression is restricted to the great arteries during embryonic and neonatal cardiovascular development. Dev Dyn. 2007 Feb;236(2):606-12. doi: 10.1002/dvdy.21054.
PubMed 17195180Aversa A, Rossi F, Francomano D, Bruzziches R, Bertone C, Santiemma V, Spera G. Early endothelial dysfunction as a marker of vasculogenic erectile dysfunction in young habitual cannabis users. Int J Impot Res. 2008 Nov-Dec;20(6):566-73. doi: 10.1038/ijir.2008.43.
PubMed 18997809Bacon CG, Mittleman MA, Kawachi I, Giovannucci E, Glasser DB, Rimm EB. A prospective study of risk factors for erectile dysfunction. J Urol. 2006 Jul;176(1):217-21. doi: 10.1016/S0022-5347(06)00589-1.
PubMed 16753404
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Serum Sclerostin Levels in Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT07902362
- Acronym / sponsor ID
- SOST-ED: Serum / 27841764830
- Conditions
- Erectile Dysfunction
- Keywords
- Sclerostin, Erectile Dsyfunction, Cardiovascular biomarkers, Vascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 28 Oct 2026 (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.
This prospective, observational case-control study aims to investigate the potential role of sclerostin-a molecule associated with cardiovascular pathologies-in the vascular pathogenesis of erectile dysfunction (ED). The study compares peripheral venous sclerostin levels between men diagnosed with ED and healthy volunteers. Additionally, it evaluates cavernosal blood sclerostin levels within the ED group to explore localized vascular changes.
Detailed description
Erectile dysfunction (ED) is closely related to vascular pathologies and is often considered an early indicator of cardiovascular disease. Sclerostin is a glycoprotein synthesized in vascular smooth muscle cells and has been investigated in relation to atherosclerosis and vascular calcification.
This study includes 50 patients with ED and 47 healthy control subjects. The presence and severity of ED are evaluated using the International Index of Erectile Function-5 (IIEF-5) questionnaire and the Erection Hardness Score (EHS). Psychological status is assessed using the Beck Depression Inventory (BDI).
The primary objective is to determine if there is a significant difference in peripheral serum sclerostin levels between the ED group and the healthy control group. The secondary objective involves the ED group exclusively, where a Combined Intracavernosal Injection and Stimulation Test (using 10 mcg alprostadil) is performed to obtain a cavernosal blood sample. This allows for a comparative analysis between peripheral and cavernosal serum sclerostin levels within the same patients to better understand localized endothelial and vascular dynamics in ED. Sclerostin levels are analyzed using the Enzyme-Linked ImmunoSorbent Assay (ELISA) method.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | –Patients diagnosed with erectile dysfunction who undergo the Combined Intracavernosal Injection and Stimulation Test (KİST) and provide peripheral and cavernosal blood samples. |
| Control Group | – | –Healthy male volunteers without erectile dysfunction who provide only peripheral venous blood samples. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients aged 18 to 65 years who presented to the Urology Outpatient Clinic of Health Sciences University Bagcilar Training and Research Hospital with complaints of erectile dysfunction, and healthy male volunteers of similar age from the same community.
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
Peripheral Serum Sclerostin Levels
Time frame: Baseline
The primary outcome is the difference in peripheral venous serum sclerostin levels between patients with erectile dysfunction and healthy controls, measured via the Enzyme-Linked ImmunoSorbent Assay (ELISA) method in ng/ml.
1 secondary outcome
Cavernosal Serum Sclerostin Levels
Time frame: Baseline (15 minutes post-injection)
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 28 Oct 2026.
- Background: PubMed 31938401Teng IC, Wang JH, Lee CJ, Hou JS, Hsu BG. Serum sclerostin as an independent marker of peripheral artery disease in elderly persons. Int J Clin Exp Pathol. 2018 May 1;11(5):2816-2821. eCollection 2018.
- Background: PubMed 35546488Golledge J, Thanigaimani S. Role of Sclerostin in Cardiovascular Disease. Arterioscler Thromb Vasc Biol. 2022 Jul;42(7):e187-e202. doi: 10.1161/ATVBAHA.122.317635. Epub 2022 May 12.
- Background: PubMed 33159018He F, Li L, Li PP, Deng Y, Yang YY, Deng YX, Luo HH, Yao XT, Su YX, Gan H, He BC. Cyclooxygenase-2/sclerostin mediates TGF-beta1-induced calcification in vascular smooth muscle cells and rats undergoing renal failure. Aging (Albany NY). 2020 Nov 6;12(21):21220-21235. doi: 10.18632/aging.103827. Epub 2020 Nov 6.
- Background: PubMed 28062506Krishna SM, Seto SW, Jose RJ, Li J, Morton SK, Biros E, Wang Y, Nsengiyumva V, Lindeman JH, Loots GG, Rush CM, Craig JM, Golledge J. Wnt Signaling Pathway Inhibitor Sclerostin Inhibits Angiotensin II-Induced Aortic Aneurysm and Atherosclerosis. Arterioscler Thromb Vasc Biol. 2017 Mar;37(3):553-566. doi: 10.1161/ATVBAHA.116.308723. Epub 2016 Dec 22.
- Background: PubMed 17195180van Bezooijen RL, Deruiter MC, Vilain N, Monteiro RM, Visser A, van der Wee-Pals L, van Munsteren CJ, Hogendoorn PC, Aguet M, Mummery CL, Papapoulos SE, Ten Dijke P, Lowik CW. SOST expression is restricted to the great arteries during embryonic and neonatal cardiovascular development. Dev Dyn. 2007 Feb;236(2):606-12. doi: 10.1002/dvdy.21054.
- Background: PubMed 18997809Aversa A, Rossi F, Francomano D, Bruzziches R, Bertone C, Santiemma V, Spera G. Early endothelial dysfunction as a marker of vasculogenic erectile dysfunction in young habitual cannabis users. Int J Impot Res. 2008 Nov-Dec;20(6):566-73. doi: 10.1038/ijir.2008.43.
- Background: PubMed 16753404Bacon CG, Mittleman MA, Kawachi I, Giovannucci E, Glasser DB, Rimm EB. A prospective study of risk factors for erectile dysfunction. J Urol. 2006 Jul;176(1):217-21. doi: 10.1016/S0022-5347(06)00589-1.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to maintain patient privacy and confidentiality, in accordance with the local ethical committee regulations. Data will only be reported and published in aggregate form.
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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?
An observational study of Erectile Dysfunction, run by Medipol University 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?
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 28 Oct 2026. 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?
Peripheral Serum Sclerostin Levels (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07902362, which also lists 7 linked publications.
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 28 Oct 2026.