Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CooperSurgical Inc.
This is a post-market prospective clinical study to be conducted at multiple centers in a single arm and open-label design to evaluate the safety of a new inserter design for Paragard® (intrauterine copper contraceptive). The study will be conducted in female subjects of child bearing potential.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Subject is a postmenarcheal and premenopausal woman of child bearing potential.
Subjects are at least 18 years of age, at the time of signing the informed consent.
Subject is overtly healthy as determined by medical evaluation.
You may not be if
Pregnancy or suspicion of pregnancy or at risk for luteal phase pregnancy
History of previous IUD complications
Abnormalities of the uterus resulting in distortion of the uterine cavity that may complicate IUD insertion
Known anatomical abnormalities of the cervix
Presence of acute pelvic inflammatory disease at the time of screening.
Postpartum endometritis.
Known or suspected uterine or cervical malignancy.
Uterine bleeding of unknown etiology.
Untreated acute cervicitis or vaginitis or other lower genital tract infection.
Conditions associated with increased susceptibility to pelvic infections.
