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Permanent Birth Control Device

Essure Device 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
Female, 21 to 44 years of age, inclusive
Body weight within range of 90-300 lbs (40 - 136 kg)
Must not have
Post-menopausal woman
Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing a new method of female sterilization that does not require surgery. The goal is to see if it is safe and effective.

Who is the study for?
Women aged 21-44 seeking permanent birth control can join this trial. They must be sexually active, not pregnant, and weigh between 90-300 lbs with healthy fallopian tubes. Participants agree to counseling and consent requirements for sterilization.
What is being tested?
The Essure System (Model ESS505) is being tested for its safety and effectiveness in providing immediate non-incisional permanent birth control by blocking the fallopian tubes to prevent pregnancy.
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but may include discomfort or pain during insertion, risk of unintended pregnancy during initial use period, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 21 and 44.
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My weight is between 90 and 300 lbs (40 - 136 kg).
Select...
Both of my fallopian tubes are healthy and open.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman who has gone through menopause.
Select...
I am scheduled for procedures in the uterus at the same time as an insert placement, excluding IUD removal.
Select...
I have had my fallopian tubes sterilized or partially/fully removed.
Select...
I am currently on corticosteroids.
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I have a condition affecting my uterus or fallopian tubes that could interfere with certain medical procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception
Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attempted

Trial Design

1Treatment groups
Experimental Treatment
Group I: ESS505Experimental Treatment1 Intervention
All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ESS505 (BAY1454033)
2013
N/A
~80

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,260 Previous Clinical Trials
25,308,785 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,206 Total Patients Enrolled

Media Library

ESS505 (BAY1454033) (Permanent Birth Control Device) Clinical Trial Eligibility Overview. Trial Name: NCT01948882 — N/A
Birth Control Research Study Groups: ESS505
Birth Control Clinical Trial 2023: ESS505 (BAY1454033) Highlights & Side Effects. Trial Name: NCT01948882 — N/A
ESS505 (BAY1454033) (Permanent Birth Control Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01948882 — N/A
~55 spots leftby Sep 2025
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