Study Completed

Contraception

Bayer Identifier:

18894

ClinicalTrials.gov Identifier:

NCT03127722

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study to assess outcomes in women undergoing either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

21 - N/A

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.

Trial summary

Enrollment Goal

990

Trial Dates

May 2017 - December 2024

Phase

N/A

Could I Receive a placebo

Products

Essure (ESS305, BAY1454032)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Active, not recruiting	New Horizons Women's Care	Chandler, 85224, United States
Active, not recruiting	Visions Clinical Research - Tucson	Tucson, 85712, United States
Active, not recruiting	Brown Stone Clinical Trials, LLC	Irving, 75061, United States
Completed	Southeast Texas Family Planning and Cancer Screening	Houston, 77074, United States
Withdrawn	Virginia Women's Center	Richmond, 23233, United States
Active, not recruiting	Office of Dr. Cindy Basinski, LLC	Newburgh, 47630, United States
Active, not recruiting	Brown Stone Clinical Trials, LLC	Irving, 75061, United States
Active, not recruiting	Columbus OB-GYN/Radiant Research	Columbus, 43213, United States
Active, not recruiting	Complete Healthcare for Women, Inc.	Columbus, 43231, United States
Active, not recruiting	Women's Integrated Health Care, PC	Grand Blanc, 48439, United States
Active, not recruiting	Women's Health Advantage	Fort Wayne, 46825, United States
Active, not recruiting	University of Tennessee Medical Center	Knoxville, 37920, United States
Active, not recruiting	Horizon Research Group of Opelousas, LLC	Eunice, 70535, United States
Active, not recruiting	OB-GYN Centre of Excellence	Chattanooga, 37404, United States
Active, not recruiting	Tufts Medical Center	Boston, 02111, United States
Active, not recruiting	Women's Health Alliance	Raleigh, 27607, United States
Active, not recruiting	Amy Brenner, MD & Associates, LLC	Mason, 45040, United States
Active, not recruiting	John H Stroger Jr. Hospital of Cook County	Chicago, 60612, United States
Active, not recruiting	Women's Health Care Group of PA	Pottstown, 19464, United States
Active, not recruiting	MetroHealth Medical Center	Cleveland, 44109-1998, United States
Active, not recruiting	Women's Health Care, PC	Newburgh, 47630, United States
Completed	Brown Stone Clinical Trials, LLC	Irving, 75061, United States
Completed	The Woman's Hospital of Texas	Houston, 77054, United States
Active, not recruiting	Wake Forest Baptist Health	Winston-Salem, 27157-1009, United States
Active, not recruiting	Jersey Shore University Medical Center	Neptune, 07753, United States
Completed	Oklahoma University	Oklahoma City, 73104, United States
Completed	University of Kentucky Albert B. Chandler Hospital	Lexington, 40536-0001, United States
Active, not recruiting	Wright State Physicians Health Center	Dayton, 45405-4534, United States
Active, not recruiting	Columbia University Medical Center	New York, 10032, United States
Completed	IU Health University Hospital	Indianapolis, 46202, United States
Active, not recruiting	AC Clinical Research	Tiffin, 44883-2820, United States
Active, not recruiting	Reading Hospital	West Reading, 19611, United States
Active, not recruiting	United Clinical Research	Huntington Beach, 90255, United States
Active, not recruiting	The Women's Health Group, P.C.	Thornton, 80229-4388, United States
Completed	St. Luke's Hospital - Allentown Campus	Allentown, 18104-9701, United States
Active, not recruiting	Precision Trials, AZ, LLC	Phoenix, 85032, United States
Completed	Ben Taub General Hospital	Houston, 77030, United States
Active, not recruiting	HWC Women’s Research Center	Englewood, 45322, United States
Active, not recruiting	HillTop Obstetrics & Gynecology	Franklin, 45005-2593, United States
Active, not recruiting	Tanner Clinic	Layton, 84041-8803, United States
Active, not recruiting	Brown Stone Clinical Trials, LLC	Irving, 75061, United States
Withdrawn	Hutzel Women’s Hospital	Detroit, 48201, United States
Completed	Physician Care Clinical Research	Sarasota, 34239, United States
Active, not recruiting	Tidewater Clinical Research, Inc.	Virginia Beach, 23456, United States
Withdrawn	Sparrow Clinical Research Institute	Lansing, 48912, United States
Active, not recruiting	Women & Infants Hospital (OGCC)	Providence, 02905, United States
Active, not recruiting	Seven Hills Women's Health Centers	Cincinnati, 45242, United States
Withdrawn	Emerald Coast Obstetrics & Gynecology	Panama City, 32405-4501, United States
Active, not recruiting	Palmetto Clinical Research (PCR)	Charleston, 29406-9126, United States
Active, not recruiting	Unified Women's Clinical Research	Winston Salem, 27103-1749, United States
Active, not recruiting	Eclipse Clinical Research	Tuscon, 85745-2696, United States
Active, not recruiting	Ohio State University	Columbus, 43210, United States
Active, not recruiting	Clinical Research Prime, LLLP	Idaho Falls, 83402-3344, United States
Active, not recruiting	Unified Women's Clinical Research, LLC	Greensboro, 27401-1207, United States
Active, not recruiting	Mid-Atlantic Permanente Research Institute	Rockville, 20852, United States
Withdrawn	Axcess Medical Research, LLC	Loxahatchee, 33470, United States
Active, not recruiting	Baptist Health Center for Clinical Research	Little Rock, 72205-6325, United States
Active, not recruiting	Women's Healthcare Associates, LLC - Tualatin	Pleasant Grove, 84062-4097, United States
Active, not recruiting	Orange Coast Women's Medical Group - Laguna Hills Office	Laguna Hills, 92653, United States
Withdrawn	Washington University School of Medicine	St. Louis, 63110, United States
Active, not recruiting	Physicians Research Options, LLC	Lakewood, 80228, United States
Completed	Altus Research	Lake Worth, 33461, United States
Active, not recruiting	M & O Clinical Research, LLC	Ft. Lauderdale, 33316, United States
Active, not recruiting	Universal Axon Clinical Research	Miami, 33166, United States
Active, not recruiting	Oregon Health and Science University	Portland, 97239, United States
Active, not recruiting	The Iowa Clinic, PC	West Des Moines, 50266-8289, United States

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
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. Based on the results of the current analyses, the outcomes observed to date are consistent with the known benefit-risk profile of Essure and with historical data for LTS. The AEs and SAEs from this study do not raise concerns for a safety signal.
Time Frame:
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
Time Frame:
Up to 60 months
Proportion of subjects with reported allergic/hypersensitivity reactions
Time Frame:
Up to 60 months
Proportion of subjects with newly diagnosed or worsening autoinmune disorders
Time Frame:
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
Time Frame:
Up to 60 months

Trial design

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

Trial Type

Interventional

Intervention Type

Procedure/Surgery

Trial Purpose

Other

Allocation

Non-randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards