[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611557":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":41,"locations":47,"responsibleParty":63,"collaborators":31,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":31,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":50,"whyStopped":31,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Ege University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Contraceptive Group","ACTIVE_COMPARATOR","Participants in this group will receive a combined oral contraceptive containing ethinylestradiol 0.03 mg and drospirenone 3 mg once daily for 21 days per cycle, followed by a 7-day pill-free interval, for 6 months. This arm serves as the active comparator to evaluate the relative efficacy of progesterone and myo-inositol therapy in menstrual regulation among women with PCOS.",[13],"Drug: Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)",{"label":15,"type":16,"description":17,"interventionNames":18},"Inositol Group","EXPERIMENTAL","Participants will receive oral inositol 2g\u002Fday for 6 months. This arm will assess the ability of myo-inositol to restore ovulatory cycles, improve ovarian morphology, and reduce hyperandrogenic symptoms in PCOS compared with oral contraceptive and progesterone groups.",[19],"Dietary Supplement: Inositol mid-level volume",{"label":21,"type":16,"description":22,"interventionNames":23},"Progesterone (Didrogesterone) Group","Participants will receive oral didrogesterone 10 mg twice daily from day 15 to day 25 of each menstrual cycle for 6 months. The efficacy of didrogesterone in restoring regular menstrual cycles and improving ovarian morphology will be compared with the oral contraceptive and myo-inositol groups.",[24],"Drug: Dydrogesterone Pill",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)","Participants will receive one tablet daily for 21 consecutive days, followed by a 7-day pill-free interval, for a total of 6 months. Used as the standard treatment arm for menstrual regulation in PCOS.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DIETARY_SUPPLEMENT","Inositol mid-level volume","Participants will receive oral inositol 2 g\u002Fday for 6 months to assess its effects on ovulatory function, menstrual cycle regulation, and reduction of hyperandrogenic symptoms.",[15],{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Dydrogesterone Pill","Participants will receive oral didrogesterone 10 mg twice daily from day 15 to day 25 of each menstrual cycle for 6 months (cyclic regimen).\n\nThis arm evaluates the efficacy of oral didrogesterone monotherapy in restoring regular menstruation, improving ovarian morphology, and alleviating hyperandrogenic symptoms in women with PCOS, compared with inositol and oral contraceptive.",[21],[42],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Sabahattin A Arı, Associate Professor","CONTACT","+905547139994","s.anil.ari.md@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":31,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Izmir Bakircay University","RECRUITING","Izmir","Menemen","35665","Turkey (Türkiye)",{"type":56,"coordinates":57},"Point",[58,59],27.13838,38.41273,{"lat":59,"lon":58},[62],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Sabahattin Anıl Arı","Associate Professor","100611557","efficacy-of-oral-contraceptive-progesterone-and-inositol-on-menstrual-regulation-in-pcos-100611557",false,"NCT07242131","Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS","Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)","Inclusion Criteria:\n\n* Female participants aged 18 to 40 years.\n* Diagnosed with polycystic ovary syndrome (PCOS) according to the ESHRE\u002FASRM (Rotterdam) criteria (presence of at least two of the following: oligo\u002Fanovulation, clinical or biochemical hyperandrogenism, polycystic ovarian morphology).\n* No significant comorbid systemic disease.\n* Willingness to participate and ability to provide written informed consent.\n* Regular follow-up availability for at least 6 months.\n\nExclusion Criteria:\n\n* Known hepatic, renal, cardiovascular, or endocrine disorders other than PCOS.\n* Pregnancy or current use of hormonal therapy within the past 3 months.\n* History of thromboembolic disease, breast cancer, or other contraindications to hormonal treatment.\n* Inability to adhere to follow-up visits or treatment regimen.\n* Severe cognitive or communication impairment that prevents proper consent or data collection.\n* Known allergy or hypersensitivity to any component of the study drugs.\n* Participation in another interventional study within the past 3 months.","FEMALE","18 Years","40 Years",{"count":78,"type":79},150,"ESTIMATED","INTERVENTIONAL",[82],"NA","This cross-sectional study aims to compare the effectiveness of oral contraceptives, oral progesterone (didrogesterone), and inositol in regulating menstrual cycles among women diagnosed with polycystic ovary syndrome (PCOS).\n\nPCOS is a common endocrine disorder affecting reproductive-aged women and is associated with menstrual irregularities, hyperandrogenism, and polycystic ovarian morphology. While oral contraceptives are the mainstay of treatment, their use may be contraindicated in patients with cardiovascular risk factors, liver dysfunction, or in those who desire pregnancy.\n\nThis study investigates whether oral progesterone and myo-inositol can serve as effective and safer alternatives for menstrual regulation and improvement of ovarian morphology and hyperandrogenic symptoms.\n\nA total of 150 women aged 15-40 years with a diagnosis of PCOS will be enrolled and divided into three equal groups:\n\nGroup 1: Oral contraceptive users\n\nGroup 2: Oral progesterone users\n\nGroup 3: Inositol users The study will assess changes in menstrual regularity, ovarian morphology (via ultrasound), and clinical features such as hirsutism and acne before and after treatment.",[85],"Polycystic Ovary Syndrome (PCOS)",[87,88,89],"Polycystic Ovary Syndrome","Menstrual Cycle","Didrogesterone","2025-12-10",{"date":92,"type":93},"2025-12-18","ACTUAL",{"date":95,"type":93},"2025-12-01",{"date":97,"type":79},"2026-06-01",{"name":5,"class":6},1]