[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uterine-hemorrhage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uterine-hemorrhage":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100599372","phase-2-transdermal-ethinyl-estradiol-and-norelgestromin-for-irregular-bleeding-in-contraceptive-implant-users-100599372",false,"NCT07083635","Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users","Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled Trial","Inclusion Criteria:\n\n* Women aged 18 years and older\n* Regular menstrual cycles : at least 1 cycle prior to contraceptive implant insertion\n* Normal pelvic examination and transvaginal ultrasound results\n* Normal cervical cancer screening within the past 3 years\n* Irregular vaginal bleeding defined as: Bleeding for more than 8 consecutive days, or Bleeding-free intervals of 15 days or less\n\nExclusion Criteria:\n\n* Previous treatment for irregular vaginal bleeding within the past 3 months\n* Pregnancy\n* Contraindications to estrogen or progestin use\n* Allergy to estrogen or progestin\n* Allergy to hormonal patches\n* Heavy vaginal bleeding causing anemia symptoms such as: Fatigue\u002FFainting\u002FDizziness","FEMALE","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to evaluate the effectiveness of transdermal contraceptive patches in treating irregular vaginal bleeding in women over 18 years old who are using contraceptive implants and experiencing abnormal vaginal bleeding. The main questions it aims to answer are:\n\n* Does transdermal ethinyl estradiol and norelgestromin patch effectively treat irregular vaginal bleeding caused by contraceptive implants compared to placebo?\n* What proportion of participants will report cessation of vaginal bleeding during treatment and remain bleeding-free at day 14 of treatment?\n* What is the safety profile and adherence rate of the transdermal patch treatment?\n\nResearchers will compare participants receiving active hormonal patches (ethinyl estradiol 600 mcg + norelgestromin 6 mg) to those receiving placebo patches to see if the hormonal treatment effectively stops irregular vaginal bleeding.\n\nParticipants will:\n\n* Apply transdermal patches for 21 days (changing patch every 7 days - total of 3 patches)\n* Attend follow-up visits at days 7, 14, 21, and 3 months (day 14 in-person, others via telephone)\n* Complete bleeding diaries and report any side effects\n* Follow-up schedule:\n\nDay 7: Telephone follow-up to assess bleeding pattern, side effects, and patch adherence Day 14: In-person visit at the clinic for comprehensive evaluation including bleeding assessment, side effects monitoring, and adherence check Day 21: Telephone follow-up to evaluate treatment completion, ongoing bleeding status, and need for additional treatment 3 months: Final telephone follow-up to assess long-term outcomes and recurrence of bleeding",[26,27,28,29],"Menstruation Disturbances","Metrorrhagia","Uterine Hemorrhage","Contraception Behavior",[31,32,33,34,35,36,37,38,39,40,41],"Contraceptive implant","Abnormal vaginal bleeding","Bothersome vaginal bleeding","Irregular vaginal bleeding","Transdermal hormonal contraception","Ethinyl estradiol","Norelgestromin","Abnormal uterine bleeding","Contraceptive-induced bleeding","Combined hormonal contraception","Hormonal contraceptive patch","RECRUITING","2025-12-09",{"date":45,"type":46},"2025-12-10","ACTUAL",{"date":48,"type":46},"2025-07-29",{"date":50,"type":20},"2026-12",{"name":52,"class":53},"Chulalongkorn University","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":54},"100589335","ultrasound-transformation-of-myomas-during-relugolix-estradiol-norethisterone-treatment-the-mysaturn-study-100589335","NCT06953076","Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study","MyomaS Aspect Transformation at Ultrasound During Relugolix Estradiol Noretisterone Treatment: MySaturn Study","MySaturn","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Pre-menopausal status.\n3. Ultrasound diagnosis of benign myometrial lesion.\n4. Symptomatic patients presenting with abnormal uterine bleeding (menorrhagia\u002Fmetrorrhagia).\n5. Availability of ultrasound images in digital format.\n\nExclusion Criteria:\n\n1. Patient refusal.\n2. Age \\\u003C 18 years.\n3. Postmenopausal women.\n4. Myometrial lesion ≤ 10 mm.\n5. Myometrial formation suspected of malignancy on ultrasound (e.g., STUMP - Uterine Leiomyosarcoma).\n6. Asymptomatic patients with uterine fibromatosis.\n7. Personal history of malignant or premalignant uterine neoplasia (e.g., STUMPs, leiomyosarcoma, atypical endometrial hyperplasia, endometrial carcinoma, cervical carcinoma).\n8. Patients with ovarian pathology.\n9. Patients currently undergoing treatment for another malignancy.\n10. Patients lacking available digital ultrasound images or whose image quality is insufficient to adequately characterize the target lesion's ultrasound features",{"count":64,"type":20},111,"OBSERVATIONAL","Uterine fibroids are benign tumors originating from the uterine muscle, affecting up to 70% of women by their 50s. Risk factors include African descent, nulliparity, obesity, and diabetes. While many fibroids are asymptomatic, 25-50% of affected women experience symptoms like heavy menstrual bleeding, pelvic pain, and pressure-related issues. Accurate diagnosis and differentiation from rare malignant tumors (e.g., uterine sarcomas) remain challenging, particularly before surgery.\n\nUltrasound is the first-line tool for evaluating fibroids, with specific features (e.g., shape, vascularity) helping distinguish benign from suspicious lesions. The MUSA guidelines standardize ultrasound terminology for myometrial assessments. Current treatment options vary based on symptoms and malignancy risk. Among pharmacologic options, the combination of relugolix, estradiol, and norethisterone has shown efficacy in reducing bleeding and pain in symptomatic fibroids, with a favorable safety profile. However, its impact on fibroid morphology and ultrasound appearance is not yet well understood.",[68,69,28,70],"Uterine Bleeding","Uterine Leiomyomas","Uterine Neoplasms",[72,73,74,75,76,77],"myomas","uterine bleeding","fibroids","relugolix","ormonal therapy","smooth muscle cells tumor","2025-08-15",{"date":80,"type":46},"2025-08-17",{"date":82,"type":46},"2025-05-02",{"date":84,"type":20},"2027-05-02",{"name":86,"class":53},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]