An observational study in Erectile Dysfunction, sponsored by Medipol University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Medipol University · Observational
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.
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's enrollment of 97 is below the median of 130 across 125 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 , (COPD) , Aortic aneurysm , Diabetes , Hypertension , Non-alcoholic steatohepatitis
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with erectile dysfunction who undergo the Combined Intracavernosal Injection and Stimulation Test (KİST) and provide peripheral and cavernosal blood samples.
Healthy male volunteers without erectile dysfunction who provide only peripheral venous blood samples.
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.
Time frame: Baseline
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.
Time frame: Baseline (15 minutes post-injection)
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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