Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
590

Inclusion Criteria

Female, 21 to 44 years of age, inclusive
Medical history indicates bilateral viable and patent fallopian tubes
Sexually active (minimum of 4 coital acts per cycle)
...
Female, 21 to 44 years of age, inclusive
Medical history indicates bilateral viable and patent fallopian tubes
Sexually active (minimum of 4 coital acts per cycle)
Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
Body weight within range of 90-300 lbs (40 - 136 kg)

Exclusion Criteria

Post-menopausal woman
Known allergy to all contrast media available for use in hysterosalpingogram
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
...
Post-menopausal woman
Known allergy to all contrast media available for use in hysterosalpingogram
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
Past fallopian tube sterilization procedure and/or total or partial salpingectomies
Suspected or confirmed pregnancy
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
Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
Currently taking corticosteroids

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
Medical history indicates bilateral viable and patent fallopian tubes
Sexually active (minimum of 4 coital acts per cycle)
...
Female, 21 to 44 years of age, inclusive
Medical history indicates bilateral viable and patent fallopian tubes
Sexually active (minimum of 4 coital acts per cycle)
Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
Body weight within range of 90-300 lbs (40 - 136 kg)

Exclusion Criteria

Post-menopausal woman
Known allergy to all contrast media available for use in hysterosalpingogram
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
...
Post-menopausal woman
Known allergy to all contrast media available for use in hysterosalpingogram
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
Past fallopian tube sterilization procedure and/or total or partial salpingectomies
Suspected or confirmed pregnancy
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
Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
Currently taking corticosteroids

Tracking Information

NCT #
NCT01948882
Collaborators
Not Provided
Investigators
Study Director: Bayer Study Director Bayer
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