Sterilization Procedures for Birth Control

Recruiting at 56 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

990 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Bayer Study Director

Principal Investigator

Bayer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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