Clinical trial NCT01948882: Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Birth control
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-09-24
Enrollment: 660
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception
timeFrame: 1 year
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception
timeFrame: 10 years
measure: 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
timeFrame: On day of placement procedure
measure: 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
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Wellington
country: United States
state: Florida
city: Fort Wayne
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Saginaw
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbia
country: United States
state: Ohio
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Hamilton
country: Canada
state: Ontario
city: Regina
country: Canada
state: Saskatchewan
city: Zwolle
country: Netherlands
city: L'Hospitalet de llobregat
country: Spain
state: Barcelona
city: Córdoba
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: