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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am a woman aged between 21 and 44.
Select...
My weight is between 90 and 300 lbs (40 - 136 kg).
Select...
Both of my fallopian tubes are healthy and open.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception
Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assessed
Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tube

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
2,237 Previous Clinical Trials
25,326,318 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,279 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

Frequently Asked Questions

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

Are there any remaining slots available in this research program?

"According to the clinicaltrials.gov database, this experimental treatment is not currently seeking participants. The trial was initially announced on September 30th 2013 and its most recent update came out November 18th 2022 - yet, there are still 61 other medical trials actively recruiting volunteers right now."

Answered by AI

Is the age range for applicants to this trial restricted in any way?

"This trial has specified that individuals aged 21 to 44 may apply. Separately, there are 22 trials for minors and 16 studies targeting the elderly population."

Answered by AI

Who has the qualifications to enroll in this medical study?

"For this trial, 660 subjects fulfilling a range of criteria are being recruited. Eligible applicants must be female between the ages 21-44 years old and have a body weight within 90 - 300 pounds (40 – 136 kg). Additionally, participants should be sexually active with 4 coital acts per cycle and agree to local requirements for contraception counselling as well as any applicable waiting periods before receiving sterilization. Furthermore, they should accept the potential risk of pregnancy while relying on contraceptive methods."

Answered by AI

What is the geographic span of this clinical trial's oversight?

"This trial is currently running at 18 different sites, located primarily in the Bronx, Norfolk and New york regions. It may be wise for interested participants to select the nearest clinic to minimize their travel requirements should they choose to enroll."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
2013. "Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01948882.
All > Pregnancy
~57 spots leftby Apr 2025
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