check_circleStudy Completed

Contraception

Bayer Identifier:

16973

ClinicalTrials.gov Identifier:

NCT01948882

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

21 - 44 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
660
Trial Dates
September 2013 - September 2024
Phase
N/A
Could I Receive a placebo
No
Products
ESS505 (BAY1454033)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Bronx, 10467, United States
Completed
Spokane, 99204, United States
Completed
Newburgh, 47630, United States
Withdrawn
Independence, 94925, United States
Completed
Houston, 77074, United States
Completed
Fort Wayne, 46825, United States
Completed
New York, 10032, United States
Completed
Asheville, 28801, United States
Completed
Córdoba, 14004, Spain
Completed
Hamilton, L8L 2X2, Canada
Completed
ZWOLLE, 8025 AB, Netherlands
Completed
L'Hospitalet de llobregat, 08906, Spain
Completed
Dallas, 75208, United States
Completed
Columbia, 60004, United States
Completed
Regina, S4S 6X3, Canada
Completed
Cincinnati, 45242, United States
Completed
Aurora, 80045, United States
Completed
Norfolk, 23507, United States
Completed
Rochester, 55905, United States
Completed
Saginaw, 48604, United States
Completed
Wellington, 33414, United States
Completed
Irving, 75062, United States
Completed
Denver, 80231, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    1 year
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    3 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception
    date_rangeTime Frame:
    10 years
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    On day of placement procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Up to 10 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Prevention
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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