Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
不适用
已完成
NCT03127722
| 适应症 | Contraception |
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| 分期 | 不适用 |
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| 申办方 | Bayer |
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| 状态 | 已完成 |
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| 受试者人数 | 990 人 |
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| 干预（药物） | Blood draw, ESSURE (BAY1454032), Laparoscopic tubal sterilization |
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| 开始日期 | 2017年5月3日 |
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| 完成日期 | 2024年12月31日 |
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| 结果公布日 | 2026年5月22日 |
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摘要
This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including: * Pelvic and/or lower abdominal pain * Abnormal uterine bleeding * Surgical intervention (including "insert removal" and hysterectomy) * Allergic, hypersensitivity, or autoimmune-like reactions
Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization
Up to 60 months · Participants
| ESSURE (BAY1454032) | 39 Participants |
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| Laparoscopic Tubal Sterilization | 28 Participants |
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Bleeding: The Proportion of Subjects Reporting AEs of Abnormal Uterine Bleeding (AUB) After Insertion of Essure System Compared to the Proportion of Subjects Reporting AEs of AUB After Laparoscopic Tubal Sterilization
Up to 60 months · Participants
| ESSURE (BAY1454032) | 59 Participants |
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| Laparoscopic Tubal Sterilization | 57 Participants |
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Proportion of Subjects With Reported Allergic/Hypersensitivity Reactions
Up to 60 months · Participants
| ESSURE (BAY1454032) | 6 Participants |
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| Laparoscopic Tubal Sterilization | 3 Participants |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。