ContraceptionNCT03127722
Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
A study testing Blood draw, ESSURE (BAY1454032) and Laparoscopic tubal sterilization in people with Contraception, run by Bayer at 57 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Blood draw, ESSURE (BAY1454032) and Laparoscopic tubal sterilization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 57 sitesUnited States
- Study dates
- 3 May 2017to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 9Show fewer
- 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.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
St. Luke's Hospital - Allentown Campus
Allentown, Pennsylvania, 18104-9701
Tufts Medical Center
Boston, Massachusetts, 02111
New Horizons Women's Care
Chandler, Arizona, 85224
Palmetto Clinical Research (PCR)
Charleston, South Carolina, 29406-9126
OB-GYN Centre of Excellence
Chattanooga, Tennessee, 37404
John H Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
Seven Hills Women's Health Centers
Cincinnati, Ohio, 45242
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998
Ohio State University
Columbus, Ohio, 43210
Columbus OB-GYN/Radiant Research
Columbus, Ohio, 43213
Complete Healthcare for Women, Inc.
Columbus, Ohio, 43231
Wright State Physicians Health Center
Dayton, Ohio, 45405-4534
HWC Women's Research Center
Englewood, Ohio, 45322
Horizon Research Group of Opelousas, LLC
Eunice, Louisiana, 70535
M & O Clinical Research, LLC
Fort Lauderdale, Florida, 33316
Women's Health Advantage
Fort Wayne, Indiana, 46825
HillTop Obstetrics & Gynecology
Franklin, Ohio, 45005-2593
Women's Integrated Health Care, PC
Grand Blanc, Michigan, 48439
Unified Women's Clinical Research, LLC
Greensboro, North Carolina, 27401-1207
Ben Taub General Hospital
Houston, Texas, 77030
The Woman's Hospital of Texas
Houston, Texas, 77054
Southeast Texas Family Planning and Cancer Screening
Houston, Texas, 77074
United Clinical Research
Huntington Beach, California, 90255
Clinical Research Prime, LLLP
Idaho Falls, Idaho, 83402-3344
IU Health University Hospital
Indianapolis, Indiana, 46202
Brown Stone Clinical Trials, LLC
Irving, Texas, 75061
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Orange Coast Women's Medical Group - Laguna Hills Office
Laguna Hills, California, 92653
Altus Research
Lake Worth, Florida, 33461
Physicians Research Options, LLC
Lakewood, Colorado, 80228
Tanner Clinic
Layton, Utah, 84041-8803
University of Kentucky Albert B. Chandler Hospital
Lexington, Kentucky, 40536-0001
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205-6325
Amy Brenner, MD & Associates, LLC
Mason, Ohio, 45040
Universal Axon Clinical Research
Miami, Florida, 33166
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Columbia University Medical Center
New York, New York, 10032
Office of Dr. Cindy Basinski, LLC
Newburgh, Indiana, 47630
Women's Health Care, PC
Newburgh, Indiana, 47630
Oklahoma University
Oklahoma City, Oklahoma, 73104
Precision Trials, AZ, LLC
Phoenix, Arizona, 85032
Women's Healthcare Associates, LLC - Tualatin
Pleasant Grove, Utah, 84062-4097
Oregon Health and Science University
Portland, Oregon, 97239
Women's Health Care Group of PA
Pottstown, Pennsylvania, 19464
Women & Infants Hospital (OGCC)
Providence, Rhode Island, 02905
Women's Health Alliance
Raleigh, North Carolina, 27607
Mid-Atlantic Permanente Research Institute
Rockville, Maryland, 20852
Physician Care Clinical Research
Sarasota, Florida, 34239
The Women's Health Group, P.C.
Thornton, Colorado, 80229-4388
AC Clinical Research
Tiffin, Ohio, 44883-2820
Visions Clinical Research - Tucson
Tucson, Arizona, 85712
Eclipse Clinical Research
Tucson, Arizona, 85745-2696
Tidewater Clinical Research, Inc.
Virginia Beach, Virginia, 23456
The Iowa Clinic, PC
West Des Moines, Iowa, 50266-8289
Reading Hospital
West Reading, Pennsylvania, 19611
Unified Women's Clinical Research
Winston-Salem, North Carolina, 27103-1749
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157-1009
About this study
Official title: An Open-label, Non-randomized, Prospective Observational Cohort Study to Assess Post-procedural Outcomes in Two Cohorts of Women Who Chose to Undergo Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
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
- Conditions
- Contraception
- Being tested
- Blood draw, ESSURE (BAY1454032), Laparoscopic tubal sterilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
Decision for either treatment will be based upon clinical practice and physician/patient counseling. In addition of routine care practice, blood draws will be performed at baseline, 12 months and 60 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization.
ESSURE (BAY1454032)Device
Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
Laparoscopic tubal sterilizationProcedure or surgery
Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| ESSURE (BAY1454032) | Experimental | 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. Receives: Procedure: Blood draw; Device: ESSURE (BAY1454032) |
| Laparoscopic tubal sterilization | Active comparator | Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care Receives: Procedure: Blood draw; Procedure: Laparoscopic tubal sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization
The proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after insertion of Essure System compared to the proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after laparoscopic tubal sterilization. Statistical analyses were exploratory and descriptive in nature and no confirmatory hypothesis testing was intended to be performed; p-values were to be interpreted as a metric for uncertainty (note: no analysis included in this final analysis provides p-values). Therefore, no adjustment for multiplicity was necessary. All endpoints and variables were analyzed by descriptive statistical methods.
Measured: Up to 60 months
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
Incidence of new onset or worsening abnormal bleeding events was based on AE reporting. If a potential bleeding AE was reported at a scheduled visit or if the subject spontaneously reports such an event to the site at some other time, the event was to be evaluated per standard AE assessment. If during the course of a scheduled PRO administration the subject indicated that she experienced abnormal bleeding that reached a preset threshold on the questionnaire, the investigator was alerted and instructed to investigate this finding in order to determine whether or not an AE occurred.
Measured: Up to 60 months
Proportion of Subjects With Reported Allergic/Hypersensitivity Reactions
For potential allergic/hypersensitivity reactions, investigators were instructed that an evaluation was to be performed in subjects who presented with symptoms that could have possibly been related to an inflammatory reaction. After the evaluation of the subject was complete, regardless of the investigator's assessment as to whether or not a hypersensitivity/allergic reaction had occurred, all information was to be forwarded to the Adjudication Committee in a blinded fashion. Final determination of whether or not a hypersensitivity/allergic event had occurred was based on the determination of this committee.
Measured: Up to 60 months
Proportion of Subjects With Newly Diagnosed or Worsening Autoimmune Disorders
Any subject presenting with symptoms indicating a potential autoimmune disorder was to be evaluated per standard medical practice. All effort was to be made to obtain records of any diagnostic workup conducted by outside physicians. NiLPT, chromium LPT, serum or plasma nickel level, and serum or plasma titanium level and serum inflammatory cytokines samples were also to be drawn by the study site. An appropriate human leukocyte antigen (HLA) panel was to be run on previously obtained baseline samples if sufficient sample existed.
After the evaluation of the subject was complete, all information was to be forwarded to the adjudication committee in a blinded fashion, regardless of investigator's assessment as to whether or not an autoimmune disorder existed. Final determination of whether or not an autoimmune disorder had occurred was based on the determination of this committee.
Measured: Up to 60 months
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
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start3 May 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127722
- Sponsor's protocol ID
- 18894
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2017
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized, Prospective Observational Cohort Study to Assess Post-procedural Outcomes in Two Cohorts of Women Who Chose to Undergo Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
- ClinicalTrials.gov ID
- NCT03127722
- Acronym / sponsor ID
- 18894
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 990 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 May 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESSURE (BAY1454032) | Experimental | Procedure: Blood draw, Device: ESSURE (BAY1454032)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. |
| Laparoscopic tubal sterilization | Active comparator | Procedure: Blood draw, Procedure: Laparoscopic tubal sterilizationSubjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- For the laparoscopic tubal sterilization group only:
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawDecision for either treatment will be based upon clinical practice and physician/patient counseling. In addition of routine care practice, blood draws will be performed at baseline, 12 months and 60 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization. | Procedure or surgery | ESSURE (BAY1454032), Laparoscopic tubal sterilization |
| ESSURE (BAY1454032)Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol. | Device | ESSURE (BAY1454032) |
| Laparoscopic tubal sterilizationDecision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol. | Procedure or surgery | Laparoscopic tubal sterilization |
Primary outcome
Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization
Time frame: Up to 60 months
The proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after insertion of Essure System compared to the proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after laparoscopic tubal sterilization. Statistical analyses were exploratory and descriptive in nature and no confirmatory hypothesis testing was intended to be performed; p-values were to be interpreted as a metric for uncertainty (note: no analysis included in this final analysis provides p-values). Therefore, no adjustment for multiplicity was necessary. All endpoints and variables were analyzed by descriptive statistical methods.
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
Time frame: Up to 60 months
Incidence of new onset or worsening abnormal bleeding events was based on AE reporting. If a potential bleeding AE was reported at a scheduled visit or if the subject spontaneously reports such an event to the site at some other time, the event was to be evaluated per standard AE assessment. If during the course of a scheduled PRO administration the subject indicated that she experienced abnormal bleeding that reached a preset threshold on the questionnaire, the investigator was alerted and instructed to investigate this finding in order to determine whether or not an AE occurred.
Proportion of Subjects With Reported Allergic/Hypersensitivity Reactions
Time frame: Up to 60 months
For potential allergic/hypersensitivity reactions, investigators were instructed that an evaluation was to be performed in subjects who presented with symptoms that could have possibly been related to an inflammatory reaction. After the evaluation of the subject was complete, regardless of the investigator's assessment as to whether or not a hypersensitivity/allergic reaction had occurred, all information was to be forwarded to the Adjudication Committee in a blinded fashion. Final determination of whether or not a hypersensitivity/allergic event had occurred was based on the determination of this committee.
Proportion of Subjects With Newly Diagnosed or Worsening Autoimmune Disorders
Time frame: Up to 60 months
Any subject presenting with symptoms indicating a potential autoimmune disorder was to be evaluated per standard medical practice. All effort was to be made to obtain records of any diagnostic workup conducted by outside physicians. NiLPT, chromium LPT, serum or plasma nickel level, and serum or plasma titanium level and serum inflammatory cytokines samples were also to be drawn by the study site. An appropriate human leukocyte antigen (HLA) panel was to be run on previously obtained baseline samples if sufficient sample existed. After the evaluation of the subject was complete, all information was to be forwarded to the adjudication committee in a blinded fashion, regardless of investigator's assessment as to whether or not an autoimmune disorder existed. Final determination of whether or not an autoimmune disorder had occurred was based on the determination of this committee.
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
Time frame: Up to 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw, ESSURE (BAY1454032) and Laparoscopic tubal sterilization in people with Contraception, run by Bayer at 57 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization (time frame: Up to 60 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.