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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03127722
Other study ID # 18894
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 3, 2017
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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) - Allergic, hypersensitivity, or autoimmune-like reactions


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 990
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Blood draw
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.
Device:
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.
Procedure:
Laparoscopic tubal sterilization
Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.

Locations

Country Name City State
United States St. Luke's Hospital - Allentown Campus Allentown Pennsylvania
United States Tufts Medical Center Boston Massachusetts
United States New Horizons Women's Care Chandler Arizona
United States Palmetto Clinical Research (PCR) Charleston South Carolina
United States OB-GYN Centre of Excellence Chattanooga Tennessee
United States John H Stroger Jr. Hospital of Cook County Chicago Illinois
United States Seven Hills Women's Health Centers Cincinnati Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Columbus OB-GYN/Radiant Research Columbus Ohio
United States Complete Healthcare for Women, Inc. Columbus Ohio
United States Ohio State University Columbus Ohio
United States Wright State Physicians Health Center Dayton Ohio
United States HWC Women's Research Center Englewood Ohio
United States Horizon Research Group of Opelousas, LLC Eunice Louisiana
United States M & O Clinical Research, LLC Fort Lauderdale Florida
United States Women's Health Advantage Fort Wayne Indiana
United States HillTop Obstetrics & Gynecology Franklin Ohio
United States Women's Integrated Health Care, PC Grand Blanc Michigan
United States Unified Women's Clinical Research, LLC Greensboro North Carolina
United States Ben Taub General Hospital Houston Texas
United States Southeast Texas Family Planning and Cancer Screening Houston Texas
United States The Woman's Hospital of Texas Houston Texas
United States United Clinical Research Huntington Beach California
United States Clinical Research Prime, LLLP Idaho Falls Idaho
United States IU Health University Hospital Indianapolis Indiana
United States Brown Stone Clinical Trials, LLC Irving Texas
United States University of Tennessee Medical Center Knoxville Tennessee
United States Orange Coast Women's Medical Group - Laguna Hills Office Laguna Hills California
United States Altus Research Lake Worth Florida
United States Physicians Research Options, LLC Lakewood Colorado
United States Tanner Clinic Layton Utah
United States University of Kentucky Albert B. Chandler Hospital Lexington Kentucky
United States Baptist Health Center for Clinical Research Little Rock Arkansas
United States Amy Brenner, MD & Associates, LLC Mason Ohio
United States Universal Axon Clinical Research Miami Florida
United States Jersey Shore University Medical Center Neptune New Jersey
United States Columbia University Medical Center New York New York
United States Office of Dr. Cindy Basinski, LLC Newburgh Indiana
United States Women's Health Care, PC Newburgh Indiana
United States Oklahoma University Oklahoma City Oklahoma
United States Precision Trials, AZ, LLC Phoenix Arizona
United States Women's Healthcare Associates, LLC - Tualatin Pleasant Grove Utah
United States Oregon Health and Science University Portland Oregon
United States Women's Health Care Group of PA Pottstown Pennsylvania
United States Women & Infants Hospital (OGCC) Providence Rhode Island
United States Women's Health Alliance Raleigh North Carolina
United States Mid-Atlantic Permanente Research Institute Rockville Maryland
United States Physician Care Clinical Research Sarasota Florida
United States The Women's Health Group, P.C. Thornton Colorado
United States AC Clinical Research Tiffin Ohio
United States Eclipse Clinical Research Tucson Arizona
United States Visions Clinical Research - Tucson Tucson Arizona
United States Tidewater Clinical Research, Inc. Virginia Beach Virginia
United States The Iowa Clinic, PC West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Unified Women's Clinical Research Winston-Salem North Carolina
United States Wake Forest Baptist Health Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain: The proportion of AEs of chronic lower abdominal and/or pelvic pain after insertion of Essure System compared to the proportion of AEs of chronic lower abdominal and/or pelvic pain after laparoscopic tubal sterilization All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. Up to 60 months
Primary Bleeding: The proportion of AEs of abnormal uterine bleeding (AUB) after insertion of Essure System compared to the proportion of AEs of AUB after laparoscopic tubal sterilization All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. Up to 60 months
Primary Hypersensitivity / allergy / autoimmune disorders: The proportion of subjects with new onset or worsening allergic/hypersensitivity reactions and newly diagnosed or worsening autoimmune disorders in Essure vs laparoscopic tubal sterilization arms All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. Up to 60 months
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 All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. Up to 60 months
Primary Patient reported outcomes for health status Medical Outcomes Study Short Form-36 Up to 60 months
Primary Patient reported outcomes for pain intensity Patient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Intensity 3a´. Pain intensity is assessed via questions and ranked across 5 levels from ´No pain´ to ´Very severe pain´. Up to 60 months
Primary Patient reported outcomes for pain interference Patient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Interference 8a´. Pain interference is assessed via questions and ranked across 5 levels from ´Not at all´ to ´Very much´. Up to 60 months
Primary Patient reported outcomes for bleeding by AMSS Aberdeen Menorrhagia Severity Scale (AMSS) is used to characterize bleeding. AMSS is a questionaire consisting of 13 items giving a total score from 0 (least severe) to 42 points (most severe). Up to 60 months
Primary Patient reported outcomes for bleeding by intermenstrual bleeding questions Two questions used to characterize intermenstrual bleeding. Up to 60 months
Primary Patient reported outcomes for centralized pain Assessed with the Fibromyalgia Survey Questionnaire At baseline
Primary Patient reported outcomes on adverse events from device reports Assessed by questionnaires to actively solicit information on adverse events found in medical device reporting (MDR) reports with Essure and control potential bias in adverse event reporting. Up to 60 months
Primary Patient reported outcomes on media sources for their medical decisioning Assessed by Social Media questionnaire to elicit information about sources of influence on medical decisions. Up to 60 months
Primary Rates of AEs in subjects undergoing Essure placement and laparoscopic tubal sterilization All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. Up to 60 months
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