A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to demonstrate that a new device inserter leads to successful and safe insertion of Paragard® IUS, comparable to the currently approved IUS inserter, in females of reproductive potential.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
119 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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