Trial Condition(s):

Contraception

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

Bayer Identifier:

16973

ClinicalTrials.gov Identifier:

NCT01948882

EudraCT Number:

Not Available

Recruitment Complete

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.

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

Trial Summary

Enrollment Goal
660
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
ESS505 (BAY1454033)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Bronx, United States, 10467

Status
Active, not recruiting
 
Locations

Investigative Site

Spokane, United States, 99204

Status
Active, not recruiting
 
Locations

Investigative Site

Newburgh, United States, 47630

Status
Active, not recruiting
 
Locations

Investigative Site

Houston, United States, 77074

Status
Active, not recruiting
 
Locations

Investigative Site

Fort Wayne, United States, 46825

Status
Active, not recruiting
 
Locations

Investigative Site

New York, United States, 10019

Status
Active, not recruiting
 
Locations

Investigative Site

Asheville, United States, 28801

Status
Active, not recruiting
 
Locations

Investigative Site

Córdoba, Spain, 14004

Status
Active, not recruiting
 
Locations

Investigative Site

Hamilton, Canada, L8N 3Z5

Status
Active, not recruiting
 
Locations

Investigative Site

ZWOLLE, Netherlands, 8025 AB

Status
Active, not recruiting
 
Locations

Investigative Site

L'Hospitalet de llobregat, Spain, 08906

Status
Active, not recruiting
 
Locations

Investigative Site

Dallas, United States, 75208

Status
Active, not recruiting
 
Locations

Investigative Site

Arlington Heights, United States, 60004

Status
Active, not recruiting
 
Locations

Investigative Site

Regina, Canada, S4S 6X3

Status
Completed
 
Locations

Investigative Site

Cincinnati, United States, 45231

Status
Active, not recruiting
 
Locations

Investigative Site

Aurora, United States, 80045

Status
Active, not recruiting
 
Locations

Investigative Site

Norfolk, United States, 23507

Status
Active, not recruiting
 
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Investigative Site

Rochester, United States, 55905

Status
Active, not recruiting
 
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Investigative Site

Saginaw, United States, 48604

Status
Active, not recruiting
 
Locations

Investigative Site

Boynton Beach, United States, 33472-2952

Status
Completed
 
Locations

Investigative Site

Irving, United States, 75062

Status
Active, not recruiting
 
Locations

Investigative Site

Aurora, United States, 80012

Status
Active, not recruiting
 

Trial Design