Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
21–44
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Female, 21 to 44 years of age, inclusive
Body weight within range of 90-300 lbs (40 - 136 kg)
Sexually active (minimum of 4 coital acts per cycle)
Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
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
You may not be if
Post-menopausal woman
Suspected or confirmed pregnancy
Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
Past fallopian tube sterilization procedure and/or total or partial salpingectomies
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
Known allergy to all contrast media available for use in hysterosalpingogram
Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
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
Clareo Health | Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
