A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
Completed · Phase 4
Conditions studied: Contraception
In brief
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.
Key facts
- Study ID
- NCT05309694
- Run by
- CooperSurgical Inc.
- People needed
- 119
- Starts
- 2022-03-04
- Expected to finish
- 2022-12-08
- Last updated by the study team
- 2023-01-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify 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 qualify 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.
- Subjects with Wilson's disease.
Where it is running
- Downtown Women's Healthcare — Denver, Colorado, United States
- South Miami Women's Health — South Miami, Florida, United States
- GYN-CARE Women's Healthcare — Atlanta, Georgia, United States
- Valley Ob-Gyn Clinic, PC — Saginaw, Michigan, United States
- Hilltop Obstetrics & Gynecology — Franklin, Ohio, United States
- Central Austin - Women Partners in Health — Austin, Texas, United States
- Austin Area Ob-Gyn & Fertility — Austin, Texas, United States
- Seattle Clinical Research Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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