N/A N=990 Other

Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT03127722 ↗

Enrolled (actual)

990

Serious AEs

5.5%

Results posted

May 2026

Primary outcome: Primary: Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization — 39; 28 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Blood draw (Procedure); ESSURE (BAY1454032) (Device); Laparoscopic tubal sterilization (Procedure)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: Bayer
Primary completion: Dec 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization	39; 28	—
PRIMARY Bleeding: The Proportion of Subjects Reporting AEs of Abnormal Uterine Bleeding (AUB) After Insertion of Essure System Compared to the Proportion of Subjects Reporting AEs of AUB After Laparoscopic Tubal Sterilization	59; 57	—
PRIMARY Proportion of Subjects With Reported Allergic/Hypersensitivity Reactions	6; 3	—
PRIMARY Proportion of Subjects With Newly Diagnosed or Worsening Autoimmune Disorders	1; 0	—
PRIMARY Proportion of Subjects Undergoing Invasive Gynecologic Surgery After Essure Placement (Excluding Second Placement Attempts), Including Essure Removal Compared to Subjects Undergoing Invasive Gynecologic Surgery After Laparoscopic Tubal Sterilization	64; 23	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Subjects who are at least 21 years of age;
Subjects of all weights will be included;
Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling.
For the Essure group only:
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU;
For the laparoscopic tubal sterilization group only:
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care.

Exclusion Criteria

Subjects who are post-menopausal;
Subjects suspected of being or confirmed pregnant;
Subjects post-partum or undergone pregnancy termination ≤6 weeks prior to scheduled procedure;
Subjects uncertain about ending fertility;
Subjects with an active upper or lower genital tract infection;
Subjects with gynecologic malignancy (suspected or known);
Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic);
Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization;
Subjects with unexplained vaginal bleeding.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03127722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.