Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
134 participants
INTERVENTIONAL
2014-03-17
2014-11-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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ESS310
All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.
ESS310 (BAY1454032)
Interventions
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ESS310 (BAY1454032)
Eligibility Criteria
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Inclusion Criteria
* Subjects seeking permanent contraception
* Subjects with body weight within range of 90-300 pounds (40 - 136 kilograms)
* Subjects for whom medical history indicates bilateral viable and patent fallopian tubes
* Subjects are able and willing to comply with the protocol required follow-up visits
* Subjects have fulfilled local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
* Subjects provide written informed consent prior to enrolment
* Subjects who have sufficient mental capacity to understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience implant and subsequent wearing of the device
* Subjects who agree that anonymized personal data will be made available to study Sponsor and requisite regional and international regulatory bodies
Exclusion Criteria
* Subjects post-partum or undergone pregnancy termination ≤6 weeks of scheduled insert placement
* Subjects who have known proximal tubal occlusion in either fallopian tube
* Subjects who have undergone fallopian tube sterilization procedure
* Subjects who have had total or partial salpingectomies
* Subjects diagnosed with tubal, endometrial, or myometrial pathology which may prevent fallopian tube ostia access
* Subjects diagnosed with unicornuate uterus
* Subjects diagnosed with active or currently being treated upper or lower pelvic infection
* Subjects with gynecologic malignancy
* Subjects who are currently taking corticosteroids
* Subjects with a known allergy to all contrast media available for use in HSG (Hysterosalpingogram)
* Subjects scheduled to undergo concomitant intrauterine procedures at the time of insert placement (e.g., endometrial ablation, fibroid resection by hysteroscopy, endometrial polypectomy). Intrauterine device removal is not considered a concomitant procedure.
* Subjects with 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
* Subjects with a close affiliation with the investigational site, e.g. closely related or affiliated with the investigator (such as dependent, employee or student of the investigational site, or sponsor's staff)
21 Years
44 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Glendale, Arizona, United States
Phoenix, Arizona, United States
Colorado Springs, Colorado, United States
Augusta, Georgia, United States
Fort Wayne, Indiana, United States
Newburgh, Indiana, United States
Grand Blanc, Michigan, United States
Saginaw, Michigan, United States
Wayne State University Physicians Group
Southfield, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Winston-Salem, North Carolina, United States
Dayton, Ohio, United States
Tennessee Women's Care, PC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Countries
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Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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17069
Identifier Type: -
Identifier Source: org_study_id
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