Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

A Multi-Center, Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the Essure® (Model ESS505) Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception

The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: ESS505 (BAY1454033)

• Study Type: Interventional
• Enrollment (Actual): 660
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 6X3
• Netherlands
  • Zwolle, Netherlands, 8025 AB
• Spain
  • Córdoba, Spain, 14004
  • Barcelona
    • L'Hospitalet de llobregat, Barcelona, Spain, 08906
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
    • Denver, Colorado, United States, 80231
  • Florida
    • Wellington, Florida, United States, 33414
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
    • Newburgh, Indiana, United States, 47630
  • Michigan
    • Saginaw, Michigan, United States, 48604
  • Minnesota
    • Rochester, Minnesota, United States, 55905
  • New York
    • Bronx, New York, United States, 10467
    • New York, New York, United States, 10032
  • North Carolina
    • Asheville, North Carolina, United States, 28801
  • Ohio
    • Cincinnati, Ohio, United States, 45242
    • Columbia, Ohio, United States, 60004
  • Texas
    • Dallas, Texas, United States, 75208
    • Houston, Texas, United States, 77074
    • Irving, Texas, United States, 75062
  • Virginia
    • Norfolk, Virginia, United States, 23507
  • Washington
    • Spokane, Washington, United States, 99204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female, 21 to 44 years of age, inclusive
• Body weight within range of 90-300 lbs (40 - 136 kg)
• Sexually active (minimum of 4 coital acts per cycle)
• Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
• Medical history indicates bilateral viable and patent fallopian tubes
• Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods

Exclusion Criteria:

• Post-menopausal woman
• Suspected or confirmed pregnancy
• Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
• Past fallopian tube sterilization procedure and/or total or partial salpingectomies
• Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
• Currently taking corticosteroids
• Known allergy to all contrast media available for use in hysterosalpingogram
• Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
• Any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESS505; All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.	Device: ESS505 (BAY1454033)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception	Evaluated after 6000 women-months of reliance have been accumulated	1 year
Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attempted	Evaluated after 3000 women-months of reliance have been accumulated (expected at the same time most subjects with implants have completed their 3 month follow-up visit)	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception	10 years
Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tube	On day of placement procedure
Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assessed	Up to 10 years

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2013
• Primary Completion (Actual): September 16, 2015
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: September 19, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (Estimated): September 24, 2013

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Birth control
• Other Study ID Numbers: 16973

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes