PriapismNCT07391709
Investigation of the Protective Effect of Alpha Lipoic Acid on Ischemic Reperfusion Damage in Ischemic Priapism in Rats
A study testing Ischemic priapism + reperfusion and Ischemic priapism + reperfusion + ALA in people with Priapism and Reperfusion Injury, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The condition known in medical terminology as 'Priapism' refers to the state of erection in the male sexual organ persisting partially or completely for more than 4 hours without sexual stimulation or orgasm. Read more about this study
- Who is it for?
- Ages 10 to 16 weeks, men onlyHealthy volunteers can take part
- Conditions the study is for
- Priapism, Reperfusion Injury
- What is being tested?
- Ischemic priapism + reperfusion and Ischemic priapism + reperfusion + ALA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2024to 10 Sep 2024
- 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 10 to 16 weeks
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Adult male Sprague-Dawley rats weighing 350-400 g.
Who cannot join
- Animals with congenital anomalies, active infection, or systemic disease.
- Animals that died before completion of the experimental protocol.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Experimental Animal Research Center
Trabzon
About this study
The condition known in medical terminology as 'Priapism' refers to the state of erection in the male sexual organ persisting partially or completely for more than 4 hours without sexual stimulation or orgasm. This 'prolonged and painful erection' is generally observed in young adults, although it can occur in all age groups, including the neonatal period. There are three main types: ischaemic (restricted blood flow), non-ischaemic (unrestricted blood flow), and recurrent 'prolonged and painful erection'. This disorder is believed to develop as a result of malfunctions in the mechanism that causes the male sexual organ to lose its erection (detumescence of the penis). Although the return of blood flow (reperfusion) to the tissue following the termination of 'long and painful erection' is necessary to preserve this structure that has been deprived of blood for a period of time, the return of blood flow itself initiates a mechanistic process that causes damage due to restricted blood flow and the return of blood flow to the tissue.
Currently, there is no effective and safe medical treatment used to prevent tissue damage caused by ischaemia-reperfusion injury in the treatment of 'long and painful erection'. Currently, there is no effective and safe medical treatment used in the treatment of 'long and painful erection' to prevent tissue damage resulting from ischaemia-reperfusion injury. Alpha-lipoic acid is an antioxidant found in some foods and naturally produced in the body. In this study, a model of 'long and painful erection' will be created in a total of 18 rats divided into 6 groups, and the possible biochemical and histopathological protective effects of alpha-lipoic acid against this condition will be investigated.
Read the detailed description
Priapism refers to a prolonged erection lasting more than four hours without any sexual stimulation, caused by a dysfunction of the mechanisms that regulate penile swelling, rigidity, and relaxation . Pathophysiologically, there are three main types of priapism: ischaemic, non-ischaemic, and recurrent (stuttering). Ischemic (veno-occlusive, low-flow) priapism is the most common type. Sickle cell anaemia, vasoactive drug use, haematological dyscrasias, heparin therapy, haemodialysis, malignancies (local or metastatic), hyperlipidaemia parenteral nutrition therapy, and trauma are among the many conditions that can cause priapism. Acute ischaemic priapism represents a medical emergency and may subsequently lead to erectile dysfunction (ED) . Ischemia-reperfusion (I/R) injury occurs with the resolution of priapism. Although reperfusion is a necessary mechanism for the preservation of ischaemic tissue, reperfusion itself initiates a pathophysiological process that causes injury. With I/R injury, neutrophils, inflammatory cytokines, and adhesion molecules with increased thrombogenicity are activated, and free oxygen radicals develop with massive intracellular Ca release . Oxidative stress damages the cell membrane and has harmful effects on the tissue, leading to permanent cellular injury. Alpha-lipoic acid (ALA) is an 8-carbon molecule first isolated from bovine liver in 1950 that can cross the blood-brain barrier. It may also be referred to as 1,2-dithiolane-3-pentanoic acid or thioctic acid . Alpha-lipoic acid (ALA) is a natural substance found in certain foods and also synthesised in the body. It is abundant in animal and plant tissues rich in mitochondrial complexes. Among plants, spinach, broccoli, and tomatoes contain the highest amounts of lipoic acid. In animal tissues, it is most abundant in the kidneys, heart, and liver. ALA is an enzymatic cofactor involved in glucose and lipid metabolism and regulates gene transcription. ALA also acts as an antioxidant because it not only improves internal antioxidant systems but also restores them and supports their production or cellular accessibility. It also effectively removes heavy metals responsible for oxidative stress from the bloodstream. ALA's most unique feature compared to other antioxidants is that it reacts as both a lipid and water-soluble compound . Pharmacologically, ALA improves glycaemic control and diabetes mellitus-related polyneuropathies; it also effectively reduces toxicities associated with heavy metal poisoning. As an antioxidant, ALA directly eliminates free radicals, chelates transition metal ions, increases cytosolic glutathione and vitamin C levels, and prevents toxicities associated with their depletion . It is used in preclinical studies and clinically in AIDS, renal lithiasis, ethanol intoxication, cerebral ischaemia, stroke, Parkinson's disease, skin inflammation, diabetic neuropathy, radiation damage, and cataract disease . This study will examine the efficacy of ALA in alleviating reperfusion injury in rat models of ischaemic priapism using biochemical and histopathological methods.
Literature review:
Publications on the subject published in PubMed, ClinicalKey, EAU, AUA Guide, National Thesis Centre, and Google Scholar were reviewed. Publications on ischaemic priapism within priapism were reviewed. These publications included a detailed examination of the pathophysiology, aetiology, interventions and treatments of priapism, and experimentally induced ischaemic priapism models. Publications containing biochemical properties related to alpha-lipoic acid and experimental studies used for treatment purposes were examined. Publications containing biomarker and histopathological examinations of serum and tissue samples examined in animal experimental models with induced ischaemia-reperfusion were reviewed.
Objective: The aim of this experimental study is to investigate the possible effects of alpha-lipoic acid on this condition biochemically and histopathologically by creating a 'long and painful erection' model in rats.
- Conditions
- Priapism, Reperfusion Injury
- Being tested
- Ischemic priapism + reperfusion, Ischemic priapism + reperfusion + ALA
- Keywords
- Priapism, Alpha Lipoic Acid, Ischemia-Reperfusion Injury, Antioxidant, Rat
- Medical subject headings
- Priapism, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic priapism + reperfusionProcedure or surgery
Also called Penile ischemia-reperfusion injury model, Penile tourniquet-induced ischemic priapism, Experimental ischemic priapism model
Ischemic priapism was induced by applying a tourniquet to the base of the penis for 4 hours, followed by reperfusion.
Ischemic priapism + reperfusion + ALAProcedure or surgery
Also called Penile tourniquet-induced ischemic priapism, Experimental ischemic priapism model, Penile ischemia-reperfusion injury model
Ischemic priapism was induced by applying a tourniquet to the base of the penis for 4 hours, followed by reperfusion.
Ischemic priapism + reperfusion + ALADrug
Also called ALA, α-Lipoic acid
Alpha-lipoic acid was administered intraperitoneally at a dose of 100 mg/kg, 30 minutes before reperfusion.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Healthy rats with no induction of ischemic priapism or reperfusion. No pharmacological treatment was administered. |
| Ischemic priapism + reperfusion | Experimental | Ischemic priapism was induced by applying a tourniquet to the base of the penis for 4 hours, followed by reperfusion. No antioxidant or pharmacological treatment was given. Receives: Procedure: Ischemic priapism + reperfusion |
| Ischemic priapism + reperfusion + ALA | Experimental | Ischemic priapism was induced by a 4-hour penile base tourniquet followed by reperfusion. Alpha-lipoic acid (ALA) was administered intraperitoneally at a dose of 100 mg/kg, 30 minutes before reperfusion. Receives: Procedure: Ischemic priapism + reperfusion + ALA; Drug: Ischemic priapism + reperfusion + ALA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum total antioxidant status (TAS) measured by Erel spectrophotometric assay
Serum total antioxidant status (TAS) will be measured using the Erel spectrophotometric assay.Unit of Measure mmol Trolox equivalent/L
Measured: 7 days after reperfusion
Change in serum total oxidant status (TOS) measured by Erel spectrophotometric assay
Serum total oxidant status (TOS) will be measured using the Erel spectrophotometric assay.Unit of Measure µmol H₂O₂ equivalent/L
Measured: 7 days after reperfusion
Change in serum glutathione peroxidase (GPx) activity measured by spectrophotometric enzyme activity assay
Serum glutathione peroxidase (GPx) activity will be measured using a spectrophotometric enzyme activity assay.Unit of Measure U/L
Measured: 7 days after reperfusion
Change in serum malondialdehyde (MDA) concentration measured by ELISA
Serum malondialdehyde (MDA) concentration will be measured using a commercial ELISA kit.Unit of Measure ng/mL
Measured: 7 days after reperfusion
Change in serum ischemia-modified albumin (IMA) concentration measured by ELISA
Serum ischemia-modified albumin (IMA) concentration will be measured using a commercial ELISA kit.Unit of Measure U/mL
Measured: 7 days after reperfusion
Secondary outcomes (2)
Change in serum tumor necrosis factor-alpha (TNF-α) concentration measured by ELISA
Serum tumor necrosis factor-alpha (TNF-α) concentration will be measured using a commercial ELISA kit.Unit of Measure pg/mL
Measured: 7 days after reperfusion
Change in penile tissue tumor necrosis factor-alpha (TNF-α) concentration measured by ELISA
Penile tissue tumor necrosis factor-alpha (TNF-α) concentration will be measured using a commercial ELISA kit and normalized to tissue protein content.Unit of Measure pg/mg protein
Measured: 7 days after reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start10 Feb 2024
- Primary completion10 Jul 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PriapismStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomised controlled group animal experiment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karadeniz Technical University
- Responsible party
- Principal investigator, İbrahim Sibal, Trabzon Kanuni Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391709
- Sponsor's protocol ID
- 2024/2
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Protective Effect of Alpha Lipoic Acid on Ischemic Reperfusion Damage in Ischemic Priapism in Rats
- ClinicalTrials.gov ID
- NCT07391709
- Acronym / sponsor ID
- 2024/2
- Conditions
- Priapism, Reperfusion Injury
- Keywords
- Priapism, Alpha Lipoic Acid, Ischemia-Reperfusion Injury, Antioxidant, Rat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Collaborators
- Karadeniz Technical University
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 6 Feb 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.
The condition known in medical terminology as 'Priapism' refers to the state of erection in the male sexual organ persisting partially or completely for more than 4 hours without sexual stimulation or orgasm. This 'prolonged and painful erection' is generally observed in young adults, although it can occur in all age groups, including the neonatal period. There are three main types: ischaemic (restricted blood flow), non-ischaemic (unrestricted blood flow), and recurrent 'prolonged and painful erection'. This disorder is believed to develop as a result of malfunctions in the mechanism that causes the male sexual organ to lose its erection (detumescence of the penis). Although the return of blood flow (reperfusion) to the tissue following the termination of 'long and painful erection' is necessary to preserve this structure that has been deprived of blood for a period of time, the return of blood flow itself initiates a mechanistic process that causes damage due to restricted blood flow and the return of blood flow to the tissue.
Currently, there is no effective and safe medical treatment used to prevent tissue damage caused by ischaemia-reperfusion injury in the treatment of 'long and painful erection'. Currently, there is no effective and safe medical treatment used in the treatment of 'long and painful erection' to prevent tissue damage resulting from ischaemia-reperfusion injury. Alpha-lipoic acid is an antioxidant found in some foods and naturally produced in the body. In this study, a model of 'long and painful erection' will be created in a total of 18 rats divided into 6 groups, and the possible biochemical and histopathological protective effects of alpha-lipoic acid against this condition will be investigated.
Detailed description
Priapism refers to a prolonged erection lasting more than four hours without any sexual stimulation, caused by a dysfunction of the mechanisms that regulate penile swelling, rigidity, and relaxation . Pathophysiologically, there are three main types of priapism: ischaemic, non-ischaemic, and recurrent (stuttering). Ischemic (veno-occlusive, low-flow) priapism is the most common type. Sickle cell anaemia, vasoactive drug use, haematological dyscrasias, heparin therapy, haemodialysis, malignancies (local or metastatic), hyperlipidaemia parenteral nutrition therapy, and trauma are among the many conditions that can cause priapism. Acute ischaemic priapism represents a medical emergency and may subsequently lead to erectile dysfunction (ED) . Ischemia-reperfusion (I/R) injury occurs with the resolution of priapism. Although reperfusion is a necessary mechanism for the preservation of ischaemic tissue, reperfusion itself initiates a pathophysiological process that causes injury. With I/R injury, neutrophils, inflammatory cytokines, and adhesion molecules with increased thrombogenicity are activated, and free oxygen radicals develop with massive intracellular Ca release . Oxidative stress damages the cell membrane and has harmful effects on the tissue, leading to permanent cellular injury. Alpha-lipoic acid (ALA) is an 8-carbon molecule first isolated from bovine liver in 1950 that can cross the blood-brain barrier. It may also be referred to as 1,2-dithiolane-3-pentanoic acid or thioctic acid . Alpha-lipoic acid (ALA) is a natural substance found in certain foods and also synthesised in the body. It is abundant in animal and plant tissues rich in mitochondrial complexes. Among plants, spinach, broccoli, and tomatoes contain the highest amounts of lipoic acid. In animal tissues, it is most abundant in the kidneys, heart, and liver. ALA is an enzymatic cofactor involved in glucose and lipid metabolism and regulates gene transcription. ALA also acts as an antioxidant because it not only improves internal antioxidant systems but also restores them and supports their production or cellular accessibility. It also effectively removes heavy metals responsible for oxidative stress from the bloodstream. ALA's most unique feature compared to other antioxidants is that it reacts as both a lipid and water-soluble compound . Pharmacologically, ALA improves glycaemic control and diabetes mellitus-related polyneuropathies; it also effectively reduces toxicities associated with heavy metal poisoning. As an antioxidant, ALA directly eliminates free radicals, chelates transition metal ions, increases cytosolic glutathione and vitamin C levels, and prevents toxicities associated with their depletion . It is used in preclinical studies and clinically in AIDS, renal lithiasis, ethanol intoxication, cerebral ischaemia, stroke, Parkinson's disease, skin inflammation, diabetic neuropathy, radiation damage, and cataract disease . This study will examine the efficacy of ALA in alleviating reperfusion injury in rat models of ischaemic priapism using biochemical and histopathological methods.
Literature review:
Publications on the subject published in PubMed, ClinicalKey, EAU, AUA Guide, National Thesis Centre, and Google Scholar were reviewed. Publications on ischaemic priapism within priapism were reviewed. These publications included a detailed examination of the pathophysiology, aetiology, interventions and treatments of priapism, and experimentally induced ischaemic priapism models. Publications containing biochemical properties related to alpha-lipoic acid and experimental studies used for treatment purposes were examined. Publications containing biomarker and histopathological examinations of serum and tissue samples examined in animal experimental models with induced ischaemia-reperfusion were reviewed.
Objective: The aim of this experimental study is to investigate the possible effects of alpha-lipoic acid on this condition biochemically and histopathologically by creating a 'long and painful erection' model in rats.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised controlled group animal experiment
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Healthy rats with no induction of ischemic priapism or reperfusion. No pharmacological treatment was administered. |
| Ischemic priapism + reperfusion | Experimental | Procedure: Ischemic priapism + reperfusionIschemic priapism was induced by applying a tourniquet to the base of the penis for 4 hours, followed by reperfusion. No antioxidant or pharmacological treatment was given. |
| Ischemic priapism + reperfusion + ALA | Experimental | Procedure: Ischemic priapism + reperfusion + ALA, Drug: Ischemic priapism + reperfusion + ALAIschemic priapism was induced by a 4-hour penile base tourniquet followed by reperfusion. Alpha-lipoic acid (ALA) was administered intraperitoneally at a dose of 100 mg/kg, 30 minutes before reperfusion. |
Who may qualify
- Ages
- 10 to 16 weeks
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adult male Sprague-Dawley rats weighing 350-400 g.
Key exclusion criteria (2 listed)
- Animals with congenital anomalies, active infection, or systemic disease.
- Animals that died before completion of the experimental protocol.
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 |
|---|---|---|
| Ischemic priapism + reperfusionAlso: Penile ischemia-reperfusion injury model, Penile tourniquet-induced ischemic priapism, Experimental ischemic priapism modelIschemic priapism was induced by applying a tourniquet to the base of the penis for 4 hours, followed by reperfusion. | Procedure or surgery | Ischemic priapism + reperfusion |
| Ischemic priapism + reperfusion + ALAAlso: Penile tourniquet-induced ischemic priapism, Experimental ischemic priapism model, Penile ischemia-reperfusion injury modelIschemic priapism was induced by applying a tourniquet to the base of the penis for 4 hours, followed by reperfusion. | Procedure or surgery | Ischemic priapism + reperfusion + ALA |
| Ischemic priapism + reperfusion + ALAAlso: ALA, α-Lipoic acidAlpha-lipoic acid was administered intraperitoneally at a dose of 100 mg/kg, 30 minutes before reperfusion. | Drug | Ischemic priapism + reperfusion + ALA |
Primary outcome
Change in serum total antioxidant status (TAS) measured by Erel spectrophotometric assay
Time frame: 7 days after reperfusion
Serum total antioxidant status (TAS) will be measured using the Erel spectrophotometric assay.Unit of Measure mmol Trolox equivalent/L
Change in serum total oxidant status (TOS) measured by Erel spectrophotometric assay
Time frame: 7 days after reperfusion
Serum total oxidant status (TOS) will be measured using the Erel spectrophotometric assay.Unit of Measure µmol H₂O₂ equivalent/L
Change in serum glutathione peroxidase (GPx) activity measured by spectrophotometric enzyme activity assay
Time frame: 7 days after reperfusion
Serum glutathione peroxidase (GPx) activity will be measured using a spectrophotometric enzyme activity assay.Unit of Measure U/L
Change in serum malondialdehyde (MDA) concentration measured by ELISA
Time frame: 7 days after reperfusion
Serum malondialdehyde (MDA) concentration will be measured using a commercial ELISA kit.Unit of Measure ng/mL
Change in serum ischemia-modified albumin (IMA) concentration measured by ELISA
Time frame: 7 days after reperfusion
Serum ischemia-modified albumin (IMA) concentration will be measured using a commercial ELISA kit.Unit of Measure U/mL
2 secondary outcomes
Change in serum tumor necrosis factor-alpha (TNF-α) concentration measured by ELISA
Time frame: 7 days after reperfusion
Change in penile tissue tumor necrosis factor-alpha (TNF-α) concentration measured by ELISA
Time frame: 7 days after reperfusion
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 6 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Priapism
Active, not recruiting
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Enrolling by invitationObservational study
ManAgement of pRiapiSm and Its Impact on Outcomes
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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 Ischemic priapism + reperfusion and Ischemic priapism + reperfusion + ALA in people with Priapism and Reperfusion Injury, run by Trabzon Kanuni Education and Research 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 2 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 6 Feb 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?
Change in serum total antioxidant status (TAS) measured by Erel spectrophotometric assay (time frame: 7 days after reperfusion). The study lists 5 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 6 Feb 2026.