[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lomonosov Moscow State University Medical Research and Educational Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100628386","phase-2-trial-of-statin-therapy-effect-on-androgen-status-and-erectile-function-in-men-100628386",false,"NCT07460960","TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men","A Randomized Controlled Trial of Statin Therapy Effect on Androgen Status and Erectile Function in Men With High and Very High Cardiovascular Risk","Inclusion Criteria:\n\n* male patients aged 40-65 years, sexually active\n* high and very high risk of cardiovascular events (The Systematic Coronary Risk Evaluation 2 (SCORE2))\n* absence of previous statin therapy for 3 months\n* there are no known cardiovascular diseases requiring the appointment of statins in high doses from the start of treatment\n* the invariance of concomitant therapy for 3 months, if the patient needs it.\n\nExclusion Criteria:\n\n* known statin intolerance\n* known hypogonadism\n* persistent forms of atrial fibrillation\n* active malignant neoplasm requiring treatment at the time of screening\n* known chronic inflammatory diseases (rheumatoid arthritis, systemic connective tissue diseases, metabolically associated fatty liver disease, etc.)\n* impaired renal function (estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73 m2) and liver (transaminase levels more than 3 times reference values, bilirubin levels more than 2 times reference values)\n* chronic heart failure\n* a well-known diagnosis of mental illness\n* alcoholism and drug addiction\n* glucocorticoid therapy and regular therapy with nonsteroidal anti-inflammatory drugs (80% of the time for 3 months before switching on)\n* participation in any other clinical trial during this trial, including participation in the trial for 30 days prior to providing informed consent\n* the patient's inability to understand the essence of the study and consent to participate in it","MALE","40 Years","65 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Aim. To study the effect of different intensities of statin therapy on androgen status and erectile function in men aged 40-65 years with high and very high cardiovascular risk. Additionally, to assess the association between sex hormone levels, erectile function parameters, and traditional cardiovascular risk factors, arterial stiffness, and endothelial function in this patient category.\n\nMaterial and methods. It is planned to conduct a prospective randomized controlled trial, including 150 male patients aged 40-65 years, undergoing routine preventive examinations in the clinic of Moscow State University, having a high and very high risk of cardiovascular diseases and meeting the inclusion criteria. Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg\u002Fday. Group Ros (n=75) will receive rosuvastatin 20 mg\u002Fday. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg\u002Fday and\u002For rosuvastatin to 40 mg\u002Fday will be performed if necessary. Patient recruitment to the study will occur over 9 months at a single research center. Patients will be monitored with an objective assessment of erectile function parameters, blood analysis (including androgen status), central arteries stiffness, and endothelial function for 6 months from the moment of activation. Follow-up visits are scheduled at 1, 3 and 6 months.\n\nResults. The expected result of testing the research hypothesis is that statin therapy will not have a negative effect on androgen status and erectile function in men. Intensive statin therapy will have a greater positive effect on endothelial function, which may lead to an improvement in men's erectile function.\n\nConclusion. The study was planned under the assumption that statin therapy would not have a negative effect on androgen status and erectile function in men aged 40-65 years. It is also suggested that the positive effect of statins on endothelial function and vascular stiffness may lead to an improvement in erectile function among men with high and very high cardiovascular risk. If the hypothesis is confirmed, the results obtained will help improve statin treatment adherence in male patients and, as a result, increase the effectiveness of prevention of cardiovascular events.",[27,28,29,30,31,32],"Erectile Dysfunction Due to Arterial Disease","Atheroscleroses","Erectile Disfunction","Endothelial Dysfunction","Androgen Profile","Testosterone",[34,35,36,37,38,39,40,41,42],"cardiovascular diseases","erectile dysfunction","androgen status","atherosclerosis","statins","statin therapy","coronary artery disease","endothelial dysfunction","testosterone","RECRUITING","2026-03-12",{"date":46,"type":47},"2026-03-16","ACTUAL",{"date":49,"type":47},"2026-03-05",{"date":51,"type":21},"2027-12",{"name":53,"class":54},"Lomonosov Moscow State University Medical Research and Educational Center","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":64,"minAge":65,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":55},"100623686","phase-2-botulinum-toxin-a-before-hemorrhoidectomy-to-prevent-postoperative-pain-100623686","NCT07399860","Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain","Effect of Internal Anal Sphincter Botulinum Toxin A Injection 7 Days Before Hemorrhoidectomy on Postoperative Pain: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial","BoTo-HEM","Inclusion Criteria:\n\n* Adults ≥18 years, male and female\n* Symptomatic grade III-IV hemorrhoidal disease (Goligher), refractory to conservative treatment\n* Scheduled for open (Milligan-Morgan) or closed (Ferguson) hemorrhoidectomy\n\nExclusion Criteria:\n\n* Known hypersensitivity to botulinum toxin A, human albumin, or local anesthetics.\n* Neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome).\n* Use of aminoglycosides or other agents interfering with neuromuscular transmission within 14 days.\n* Coagulopathy or ongoing anticoagulant therapy not suitable for perioperative interruption.\n* Active anorectal infection, fissure, abscess, or inflammatory bowel disease in the active phase.\n* Previous anal sphincter surgery or baseline fecal incontinence.\n* Pregnancy or breastfeeding.\n* ASA ≥ III or significant systemic disease compromising anesthesia or wound healing.\n* Participation in another interventional clinical trial within 30 days.","ALL","18 Years",{"count":67,"type":21},292,[24],"Hemorrhoidectomy is an effective surgical treatment for advanced hemorrhoidal disease but is often associated with significant postoperative pain, which may delay recovery. One of the main contributors to pain after hemorrhoidectomy is spasm and increased tone of the internal anal sphincter.\n\nThis randomized, double-blind, placebo-controlled clinical trial evaluates whether preoperative injection of botulinum toxin type A into the internal anal sphincter, performed seven days before hemorrhoidectomy, can reduce postoperative pain compared with placebo. Adult patients with grade III-IV hemorrhoids scheduled for excisional hemorrhoidectomy will be randomized to receive either botulinum toxin A or saline injection prior to surgery.\n\nPostoperative pain intensity, analgesic consumption, complications, functional outcomes, and patient satisfaction will be assessed during the first 30 days after surgery.",[71,72],"Hemorrhoids","Postoperative Pain",[74,75,76,77],"Hemorrhoidectomy","Botulinum toxin","Postoperative pain","Anal sphincter spasm","2026-03-07",{"date":80,"type":47},"2026-03-10",{"date":82,"type":47},"2026-02-01",{"date":84,"type":21},"2028-01",{"name":53,"class":54},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":55},"100582941","phase-1-study-of-tolerability-safety-pharmacokinetics-pharmacodynamics-and-preliminary-efficacy-of-the-medicinal-product-medireg-100582941","NCT06869863","Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg®","Open Single-center Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg® (Human Mesenchymal Stromal Cell Secretome), Lyophilizate for Preparation of Solution for Injection in Patients with Severe Spermatogenesis Disorders","MARS","Inclusion Criteria:\n\n* 1\\. Male patients aged 21-60 years at the time of inclusion in the study. 2. Persistent severe disorders of spermatogenesis, manifested as severe oligoasthenoteratozoospermia (OAT)\\*, non-obstructive azoospermia, high sperm DNA fragmentation (30% or more), including those caused by secretory infertility according to dynamic control of spermogram (at least 12 months from the moment of inclusion in the study).\n\n  * \"Persistent severe OAT\" should be considered as disorders when sperm concentration \\\u003C5 million\u002FmL, progressively motile sperm \\\u003C13% and\u002For total number of progressively motile sperm in the ejaculate (PMPM) \\\u003C5 million, with the proportion of normal sperm \\\u003C1% according to the dynamic control of spermogram (at least 12 months from the moment of inclusion in the study).\n\n    3\\. inability to conceive against the background of \"severe forms\" of male infertility, not amenable to treatment, including assisted reproductive technologies, within 12 months from the moment of diagnosis or refusal to use assisted reproductive technologies.\n\n    4\\. Voluntarily signed Informed consent by the patient to participate in the clinical trial.\n\n    5\\. Willingness of patients and their sexual partners to use reliable contraceptive methods (combination of at least 2 methods, including 1 barrier method, e.g., use of spermicide and condom) from the time of signing the informed consent until at least 1 month after completion of study participation.\n\n    6\\. Patient willingness to follow all the requirements of the Protocol.\n\nExclusion Criteria:\n\n* 1\\. Age younger than 21 and older than 60 years at the time of inclusion in the study.\n\n  2\\. developmental anomalies of the genitourinary system (according to bladder and kidney ultrasound).\n\n  3\\. surgical interventions on genitourinary organs in the history, except for surgical interventions associated with assisted reproductive technologies. 4.\n\n  4\\. Systemic diseases requiring administration of corticosteroids, cytostatics, radiation therapy.\n\n  5\\. Inflammatory diseases of the urinary and\u002For reproductive system. 6. Infectious diseases (including STDs) of the urinary and\u002For reproductive system.\n\n  7\\. Hereditary factors of infertility: (Klinefelter syndrome (all variants), autosomal abnormalities (all variants), carrying the cystic fibrosis gene (all variants), presence of Y-chromosome microdeletions (all AZF variants), autosomal defects with severe phenotypic abnormalities and infertility (Prader-Willi, Bardet-Biedl, Noonan syndromes, myotonic dystrophy, dominant polycystic kidney disease, 5-alpha-reductase enzyme deficiency, etc.). д.).\n\n  8\\. Obstructive azoospermia by history or established by screening examination. 9. Positive test for HIV, hepatitis B and C, syphilis. 10. Severe liver failure or active liver disease (transaminase activity exceeding 5 times the upper limit of the local laboratory norm).\n\n  11\\. Renal dysfunction with serum creatinine levels exceeding 120 µmol\u002FL. 12. Cardiovascular diseases in the history within 6 months before inclusion in the study, such as myocardial infarction, angina pectoris, severe ventricular arrhythmia, heart failure (NYHA class II-IV).\n\n  13\\. Neurologic (Parkinson's disease) and\u002For psychiatric illnesses with a history or established by screening examination.\n\n  14\\. Cancer with a history of cancer or as determined by screening examination (as determined by OBP and renal ultrasound, bladder ultrasound, prostate TRUS).\n\n  15\\. Hypersensitivity to any of the components of the study drug in the history. 16. Mental illness, severe cognitive impairment, need to take tranquilizers, neuroleptics and\u002For antidepressants during this study.\n\n  17\\. Severe somatic illnesses that, in the opinion of the investigator, may affect the patient's safety and ability to comply with the Protocol.\n\n  18\\. A history of drug dependence. 19. Positive urinalysis for psychotropic and narcotic drugs, psychoactive medications.\n\n  20\\. Intake of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to 1⁄2 liter of beer, 200 ml of wine, or 50 ml of alcohol) or a history of alcoholism.\n\n  21\\. Detection of alcohol vapor in breath 22. Participation in another clinical trial currently or in the previous 30 days prior to the screening visit.\n\n  23\\. Patient's inability to understand or comply with study procedures or patient's refusal to cooperate with a particular investigator","21 Years","60 Years",{"count":97,"type":21},80,[99,24],"PHASE1","The study is open to patients with severe forms of male infertility (non-obstructive disorders of spermatogenesis, including azoospermia).\n\nThe Phase I\u002FII clinical trial is being conducted at the Lomonosov Moscow State University and is aimed at studying the efficacy and safety of the innovative drug \"MediReg® (Human Mesenchymal Stromal Cell Secretome)\", lyophilizate for preparation of solution for injection, 1.0 ml\u002Fdose for treatment of male infertility. The study was approved by the Ministry of Health of the Russian Federation. The study is planned to include men aged 21 to 60 years with severe spermatogenesis disorders manifested as severe oligoasthenoteratozoospermia (OAT), non-obstructive azoospermia, high sperm DNA fragmentation (30% and more) and faced with the inability to conceive, including with the help of assisted reproductive technologies within 12 months from the date of diagnosis The aim of the therapy is to improve the spermogram indicators in order to increase the chances of successful use of assisted reproductive technologies.\n\nThe drug is injected once under the protein sheath of both testicles. Observation in 1 week after the drug administration is carried out in hospital. Follow-up is performed by outpatient visits to the research center.\n\nThe clinical trial is planned to enroll at least 80 adult patients aged 21 to 60 years with severe spermatogenesis disorders The study will include 3 periods:Screening Period - Day -15...0.\n\n, Period of study drug administration and inpatient follow-up - Day 1 through Day 7., Follow-up period - through Day 90.\n\nThe total duration of participation in the study, including the screening period and the follow-up period, will not exceed 119 days. After the end of the study period, the study will be followed up for 1 year to record delayed adverse events.",[102,103,104,105],"Azoospermia, Nonobstructive","Teratospermia","Oligospermia","Men Infertility",[107,108],"men infertility","azoospermia","2025-03-05",{"date":111,"type":47},"2025-03-11",{"date":113,"type":47},"2024-11-26",{"date":115,"type":21},"2025-12",{"name":53,"class":54},""]