Status:
COMPLETED
A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
Lead Sponsor:
CooperSurgical Inc.
Conditions:
Contraception
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 reprodu...
Detailed 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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2022
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT05309694
Start Date
March 4 2022
End Date
December 8 2022
Last Update
January 20 2023
Active Locations (8)
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1
Downtown Women's Healthcare
Denver, Colorado, United States, 80218
2
South Miami Women's Health
South Miami, Florida, United States, 33143
3
GYN-CARE Women's Healthcare
Atlanta, Georgia, United States, 30363
4
Valley Ob-Gyn Clinic, PC
Saginaw, Michigan, United States, 48602