Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
590

Inclusion Criterias

Female, 21 to 44 years of age, inclusive
Medical history indicates bilateral viable and patent fallopian tubes
Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
...
Female, 21 to 44 years of age, inclusive
Medical history indicates bilateral viable and patent fallopian tubes
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)
Sexually active (minimum of 4 coital acts per cycle)

Exclusion Criterias

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

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 Criterias

Female, 21 to 44 years of age, inclusive
Medical history indicates bilateral viable and patent fallopian tubes
Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
...
Female, 21 to 44 years of age, inclusive
Medical history indicates bilateral viable and patent fallopian tubes
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)
Sexually active (minimum of 4 coital acts per cycle)

Exclusion Criterias

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

Locations

Aurora, Colorado, 80045
Newburgh, Indiana, 47630
Córdoba, 14004
Aurora, Colorado, 80012
Asheville, North Carolina, 28801
...
Aurora, Colorado, 80045
Newburgh, Indiana, 47630
Córdoba, 14004
Aurora, Colorado, 80012
Asheville, North Carolina, 28801
Zwolle, 8025 AB
Dallas, Texas, 75208
Bronx, New York, 10467
Fort Wayne, Indiana, 46825
Rochester, Minnesota, 55905
L'Hospitalet de llobregat, Barcelona, 08906
Norfolk, Virginia, 23507
Irving, Texas, 75062
Arlington Heights, Illinois, 60004
Regina, Saskatchewan, S4S 6X3
Hamilton, Ontario, L8N 3Z5
Houston, Texas, 77074
New York, New York, 10019
Boynton Beach, Florida, 33472-2952
Spokane, Washington, 99204
Cincinnati, Ohio, 45231
Saginaw, Michigan, 48604

Tracking Information

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