Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
Last updated on April 2022Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 590
Inclusion Criteria
- Female, 21 to 44 years of age, inclusive
- Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
- Body weight within range of 90-300 lbs (40 - 136 kg)
- ...
- Female, 21 to 44 years of age, inclusive
- Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
- Body weight within range of 90-300 lbs (40 - 136 kg)
- Sexually active (minimum of 4 coital acts per cycle)
- 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
- Past fallopian tube sterilization procedure and/or total or partial salpingectomies
- Known allergy to all contrast media available for use in hysterosalpingogram
- ...
- Post-menopausal woman
- Past fallopian tube sterilization procedure and/or total or partial salpingectomies
- Known allergy to all contrast media available for use in hysterosalpingogram
- Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
- Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
- 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
- Suspected or confirmed pregnancy
- 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
Summary
- Conditions
- Contraception
- Type
- Interventional
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
Participation Requirements
- Age
- Between 21 years and 44 years
- Gender
- Only females
Inclusion Criteria
- Female, 21 to 44 years of age, inclusive
- Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
- Body weight within range of 90-300 lbs (40 - 136 kg)
- ...
- Female, 21 to 44 years of age, inclusive
- Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
- Body weight within range of 90-300 lbs (40 - 136 kg)
- Sexually active (minimum of 4 coital acts per cycle)
- 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
- Past fallopian tube sterilization procedure and/or total or partial salpingectomies
- Known allergy to all contrast media available for use in hysterosalpingogram
- ...
- Post-menopausal woman
- Past fallopian tube sterilization procedure and/or total or partial salpingectomies
- Known allergy to all contrast media available for use in hysterosalpingogram
- Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
- Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
- 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
- Suspected or confirmed pregnancy
- 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
Tracking Information
- NCT #
- NCT01948882
- Collaborators
- Not Provided
- Investigators
- Study Director: Bayer Study Director Bayer