Recruitment

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