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NCT03127722 · ClinicalTrials.gov registry record · NA
Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
A NA study, sponsored by Bayer.
- Completed
- Registry status
- NA
- Development phase
- 990
- Enrollment target
NCT03127722: Completed NA study, sponsored by Bayer.
NCT03127722 is a NA study that has completed, run by Bayer. The registered enrollment target is 990 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03127722, a NA study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- NA
- Development phase
- 990 participants
- Enrollment target
Study 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
Primary Outcome
The proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after insertion of Essure System compared to the proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after laparoscopic tubal sterilization. Statistical analyses were exploratory and descriptive in nature and no confirmatory hypothesis testing was intended to be performed; p-values were to be interpreted as a metric for uncertainty (note: no analysis included in this final an
Interventions
- PROCEDURE Blood draw
- DEVICE ESSURE (BAY1454032)
- PROCEDURE Laparoscopic tubal sterilization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 990 participants |
| Start Date | 2017-05-03 |
| Est. Completion | 2024-12-31 |
| Phase | NA |
What the finished NCT03127722 record still lists
NCT03127722 is an interventional study that assigns participants to a tested intervention. The registered 990 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 3 interventions - of which Blood draw is the first listed.
NCT03127722 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03127722 about?
NCT03127722 is a clinical study titled "Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization". 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" ...
What is the current status of trial NCT03127722?
This trial is currently completed. It is a NA study. The enrollment target is 990 participants. The study started on 2017-05-03. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT03127722?
The interventions under investigation include: Blood draw (PROCEDURE), ESSURE (BAY1454032) (DEVICE), Laparoscopic tubal sterilization (PROCEDURE).
Who is sponsoring clinical trial NCT03127722?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03127722's enrollment target sits among peer trials
990 121st of 2000 higher than 1,879 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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