Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
該当なし
完了
NCT03127722
| 対象疾患 | Contraception |
|---|
| 相 | 該当なし |
|---|
| スポンサー | Bayer |
|---|
| ステータス | 完了 |
|---|
| 参加者数 | 990 名 |
|---|
| 介入（薬剤） | Blood draw, ESSURE (BAY1454032), Laparoscopic tubal sterilization |
|---|
| 開始日 | 2017年5月3日 |
|---|
| 完了日 | 2024年12月31日 |
|---|
| 結果公開日 | 2026年5月22日 |
|---|
概要
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 |
|---|
| Laparoscopic Tubal Sterilization | 28 Participants |
|---|
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 |
|---|
| Laparoscopic Tubal Sterilization | 57 Participants |
|---|
Proportion of Subjects With Reported Allergic/Hypersensitivity Reactions
Up to 60 months · Participants
| ESSURE (BAY1454032) | 6 Participants |
|---|
| Laparoscopic Tubal Sterilization | 3 Participants |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。