Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
N/A
Completed
NCT03127722
| Condition | Contraception |
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| Phase | N/A |
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| Sponsor | Bayer |
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| Status | Completed |
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| Enrollment | 990 participants |
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| Interventions | Blood draw, ESSURE (BAY1454032), Laparoscopic tubal sterilization |
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| Start date | May 3, 2017 |
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| Completion date | Dec 31, 2024 |
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| Results posted | May 22, 2026 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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