[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polycystic-ovary-syndrome-pcos-women\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polycystic-ovary-syndrome-pcos-women":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100585024","phase-2-semaglutide-in-women-with-polycystic-ovary-syndrome-and-obesity-100585024",false,"NCT06896981","Semaglutide in Women With Polycystic Ovary Syndrome and Obesity","Comparison Between the Effects of Low-Dose Semaglutide With Metformin vs. Metformin Alone Over Metabolic Profile in Obese Polycystic Ovary Syndrome: A Phase II Randomized Controlled Trial","Inclusion Criteria:\n\nReproductive-aged women with PCOS diagnosed according to International evidence based guidelines 2023 and obesity\n\nExclusion Criteria:\n\n1. Having DM, other significant systemic diseases- chronic kidney disease (eGFR \\\u003C60mL\u002Fminute\u002F 1.73 m2 BSA), chronic liver disease (ALT \\>3 × ULN), and heart failure\n2. Patients having PCOS mimicking endocrine disorders (untreated thyroid dysfunctions, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, acromegaly, hypothalamic disorder etc.)\n3. Those taking any other weight loss medications (eg., orlistat, liraglutide) within the last 3 months\n4. Those who have undergone bariatric surgery\n5. Any conditions causing weight loss (thyrotoxicosis, Addison's disease, chronic infection, connective tissue disorder, cancer, etc)\n6. Secondary causes of obesity (major mood disorders, steroids, valproate, oral contraceptives, etc)\n7. Contraindications for semaglutide: personal or family history of medullary carcinoma of the thyroid, history of acute pancreatitis, gallbladder disease\n8. Planning for pregnancy or current pregnancy\u002F lactation","FEMALE","10 Years","45 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder that is frequently associated with metabolic features, including obesity. Improvement of metabolic manifestations helps in the control of symptoms, including subfertility. Metformin has been commonly used to decrease insulin resistance and weight in PCOS patients suffering from obesity. Glucagon-like peptide (GLP-1) agonist semaglutide is also effective in managing different metabolic features, including obesity and insulin resistance. There is limited data about using a combination of semaglutide and metformin in women with PCOS suffering from obesity. This study aims to compare the metabolic changes after giving a combination of low-dose semaglutide and metformin vs. metformin alone over 12 weeks among women with PCOS and obesity. This open label randomized trial will be conducted in the Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University (BSMMU). After obtaining informed written consent, a total of 30 patients with PCOS and obesity will be enrolled conveniently (sampling) in the study as per inclusion and exclusion criteria from the outdoor, indoor, and PCOS clinic, Endocrinology, BSMMU. Study participants will be divided into two groups randomly by a computerized random number generator (allocation). One study arm will be treated with low-dose subcutaneous semaglutide (0.25 mg\u002Fweek for 4 weeks followed by 0.5mg per week for 12 weeks) in combination with metformin (500 mg bid). Another study arm will receive monotherapy with metformin (500 mg bid) for treatment. Both arms will receive standard unified lifestyle advices. Patients will be followed every four weeks for clinical data for up to twelve weeks. Laboratory tests will be done at baseline and the final follow-up in an 8 - 12 hours of fasting state. Two mL of blood will be used to measure glucose using the glucose oxidase method on the same day of sample collection. The remaining three mL of blood will be centrifuged, the serum will be separated and analyzed for insulin, TT, SHBG, ALT and lipid profiles on the same day. All the clinical and biochemical information will be documented in a pretested, semi-structured case record form. Recorded data will be entered, edited, and analyzed by SPSS software version 25.0. Data will be expressed as frequencies \\& percentages (%) for qualitative values and mean \\& standard deviation (±SD) or median \\& inter-quartile range (IQR) for quantitative values depending on their distribution. Kaplan Meier Curve will be used to show the comparison between primary outcomes. For quantitative variables, a comparison between two groups will be done using Mann-Whitney U test, and within a group, a paired t-test or Wilcoxon test will be used. For qualitative variables, a comparison between two groups will be tested using Pearson's chi-square test and within the group by the McNemar test. Regression Analysis will be done to correlate between treatment and outcome. Any p-value below 0.05 will be considered statistically significant. Confidentiality will be strictly maintained. Informed written consent will be taken from patients.",[28,29],"Polycystic Ovary Syndrome (PCOS) Women","Obesity",[31,29,32,33],"Polycystic ovary syndrome","Semaglutide","Metformin","RECRUITING","2025-03-27",{"date":37,"type":38},"2025-04-02","ACTUAL",{"date":40,"type":38},"2025-02-01",{"date":42,"type":21},"2025-12-31",{"name":44,"class":45},"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":46},"100580087","health-related-quality-of-life-of-women-with-polycystic-ovary-syndrome-at-sohag-university-hospital-100580087","NCT06832735","Health-related Quality of Life of Women with Polycystic Ovary Syndrome At Sohag University Hospital","Inclusion Criteria:\n\n* • Female cases between 18 and 45.\n\n  * Females diagnosed with PCOS per Rotterdam criteria , the most commonly accepted and used for PCOS, a diagnosis is confirmed if any two of the three features (hyperandrogenism, oligomenorrhea or anovulation, and polycystic ovaries) are present in a woman of reproductive age\n\nExclusion Criteria:\n\n* • Females below 18 years old.\n\n  * Females above 45 years old.\n  * Patients having major life event or problem also affecting quality of life.","18 Years",{"count":55,"type":21},352,"OBSERVATIONAL","It is well-established that PCOS women suffer from anxiety, depression, and markedly reduced QoL ,but There has not yet been a nationally representative study to evaluate the PCOS health related Qol and factors affecting it among women in Egypt. So here we try to cover this gap in this study that will be designed to record the QOL of women with PCOS and factors affecting it.\n\nThis study aims to assess the health related quality of life of polycystic ovary syndrome and determine factors affecting the HRQOL",[28],[60,61,62,63],"PCOS","Quality of life","PCOSQ","BMI","NOT_YET_RECRUITING","2025-02-12",{"date":67,"type":38},"2025-02-18",{"date":69,"type":21},"2025-03",{"date":71,"type":21},"2025-10-01",{"name":73,"class":45},"Sohag University"]