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Device

Sterilization Procedures for Birth Control

N/A
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects who are at least 21 years of age
For the Essure group: Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

Study Summary

This trial is comparing post-procedural outcomes for women who chose either hysteroscopic sterilization or laparoscopic tubal sterilization.

Who is the study for?
This trial is for women at least 21 years old choosing permanent birth control via Essure® insert or laparoscopic sterilization. Candidates must not have genital infections, be uncertain about ending fertility, have previous sterilization attempts, or be post-menopausal or recently pregnant.Check my eligibility
What is being tested?
The study compares outcomes between two birth control procedures: hysteroscopic sterilization (Essure®) and laparoscopic tubal sterilization. It focuses on pain, abnormal bleeding, need for additional surgery, and potential allergic reactions post-procedure.See study design
What are the potential side effects?
Possible side effects include pelvic or lower abdominal pain, abnormal uterine bleeding, the necessity of surgical intervention such as insert removal or hysterectomy, and allergic or autoimmune-like reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 21 years old or older.
Select...
I am choosing the Essure method for sterilization and meet all the requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bleeding: The proportion of AEs of abnormal uterine bleeding (AUB) after insertion of Essure System compared to the proportion of AEs of AUB after laparoscopic tubal sterilization
Hypersensitivity / allergy / autoimmune disorders: The proportion of subjects with new onset or worsening allergic/hypersensitivity reactions and newly diagnosed or worsening autoimmune disorders in Essure vs laparoscopic tubal sterilization arms
Pain: The proportion of AEs of chronic lower abdominal and/or pelvic pain after insertion of Essure System compared to the proportion of AEs of chronic lower abdominal and/or pelvic pain after laparoscopic tubal sterilization
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ESSURE (BAY1454032)Experimental Treatment2 Interventions
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented.
Group II: Laparoscopic tubal sterilizationActive Control2 Interventions
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood draw
2021
Completed Phase 4
~6290

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,237 Previous Clinical Trials
25,325,988 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,260,949 Total Patients Enrolled

Media Library

ESSURE (BAY1454032) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03127722 — N/A
Birth Control Research Study Groups: Laparoscopic tubal sterilization, ESSURE (BAY1454032)
Birth Control Clinical Trial 2023: ESSURE (BAY1454032) Highlights & Side Effects. Trial Name: NCT03127722 — N/A
ESSURE (BAY1454032) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03127722 — N/A
Birth Control Patient Testimony for trial: Trial Name: NCT03127722 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any Canadian healthcare facilities conducting this clinical research?

"This research is currently being conducted at 57 different medical sites throughout the United States. Some of these locations include Indianapolis, West Des Moines and Lake Worth. It would be prudent to select a clinic nearest you in order to reduce travelling strains if participating in this trial."

Answered by AI

Are there any opportunities for participation in this research endeavor?

"According to clinicaltrials.gov, the original posting for this medical trial was made on May 3rd 2017 and its most recent edit took place on November 18th 2022 - indicating that it is no longer recruiting participants. However, there are other 61 trials currently seeking patients."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Altus Research

Why did patients apply to this trial?

I have tried lot of different antidepression med's which never seem to help my depression.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
2017. "Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03127722.
~87 spots leftby Dec 2024
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