Sterilization Procedures for Birth Control

No longer recruiting at 57 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Bayer

Disqualifiers: Post-menopausal, Pregnant, Genital infection, Gynecologic malignancy, Prior sterilization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of permanent birth control procedures for women: hysteroscopic sterilization (using the Essure device) and laparoscopic tubal sterilization. The researchers aim to understand how these procedures affect pain, unusual bleeding, and the need for additional surgeries. The trial will also assess any allergic or immune system reactions. Women planning to undergo one of these procedures, with no medical contraindications, can consider participating. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future birth control options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these sterilization procedures are safe?

Research has shown that both Essure and laparoscopic tubal sterilization come with specific safety considerations. Essure, a device for permanent birth control, has been linked to issues such as ongoing pain, tearing of the uterus or fallopian tubes, and the device moving from its original position. Additionally, one study found a higher rate of certain safety concerns with Essure compared to other methods.

Laparoscopic tubal sterilization is generally considered safe, with a low chance of requiring additional surgery due to complications. However, this method can sometimes fail, meaning it might not always prevent pregnancy.

Both methods have their advantages and disadvantages. Carefully considering these factors is crucial when thinking about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ESSURE procedure because it offers a non-surgical option for permanent birth control. Unlike traditional laparoscopic tubal sterilization, which involves incisions and anesthesia, ESSURE is a hysteroscopic technique that can be performed without incisions, often in a doctor's office. This minimally invasive approach reduces recovery time and may lower the risks associated with surgery. Additionally, ESSURE does not require general anesthesia, making it a less daunting choice for women seeking permanent contraception.

What evidence suggests that this trial's treatments could be effective for sterilization procedures?

This trial will compare two sterilization procedures for birth control: Essure and laparoscopic tubal sterilization. Research has shown that both methods are effective for permanent birth control. One study found that Essure was successfully placed in 97% of cases, with 93% of patients satisfied with the procedure. Essure also has a lower chance of pregnancy compared to tubal ligation, with about 6% of women becoming pregnant. For laparoscopic tubal sterilization, real-world failure rates range from 2.9% to 5.2%. Another study found that 97.59% of women did not become pregnant over eight years after using the laparoscopy method. Both methods offer reliable options for those seeking permanent birth control. ^{1 3 6 7 8}

Who Is on the Research Team?

Bayer Study Director

Principal Investigator

Bayer

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am choosing laparoscopic sterilization and have no medical reasons preventing me from having it.

I am 21 years old or older.

Subjects of all weights will be included

Exclusion Criteria

I have or might have a cancer that started in my reproductive organs.

I have attempted a sterilization procedure before.

I am scheduled for certain procedures at the same time as my insert placement, but not for an IUD removal or sterilization.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-procedural outcomes such as pain, bleeding, and adverse events

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• ESSURE (BAY1454032)
• Laparoscopic tubal sterilization

Trial Overview 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.

How Is the Trial Designed?

Group I: ESSURE (BAY1454032) Experimental Treatment 2 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 sterilization Active Control 2 Interventions

Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11787907/

results of the first Essure pbc clinical study Of women wearing the device for up to two years rate, 97% rated it to be very good to excellent. There have been no pregnancies reported in 1894 woman-months of ...

2. fda.gov fda.gov/medical-devices/essure-permanent-birth-control/problems-reported-essure

Problems Reported with Essure In 2023, the FDA received 3,626 medical device reports related to Essure, followed by 1,606 reports received in 2022, 3,701 reports received in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211513000249

Essure® permanent birth control effectiveness: a seven- ... A recent study on Essure procedures in France found a placement success rate of 97%, with 93% of patients satisfied or very satisfied [9]. Despite the large ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf2/p020014b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA CDRH found the Essure™ System to be safe and effective for permanent birth control. In reaching this conclusion, CDRH co nsidered long-term effectiveness ...

5. pcori.org pcori.org/research-results/2017/comparing-essurer-and-tubal-ligation-prevent-pregnancy

Comparing Essure® and Tubal Ligation to Prevent ... What were the results? · Had lower pregnancy rates. About 6 percent of women who had Essure had a pregnancy compared with 7 percent who had tubal ligation. · Were ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10374426/

Safety reporting of Essure medical device: a qualitative and ... Reported adverse events include persistent pain, perforation of the uterus and fallopian tubes, intra-abdominal or pelvic device migration, ...

7. medtechdive.com medtechdive.com/news/fda-bayer-essure-data-update/698266/

FDA posts updated safety data on Bayer's Essure, notes ... A postmarket surveillance study has linked Bayer's Essure birth-control implant to a numerically higher rate of some safety outcomes than ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01948882

Evaluation of Safety and Effectiveness of the Essure ... The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy.