A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
Sponsored by CooperSurgical Inc.
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Subjects with Wilson's disease.
