A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
- Conditions
- Contraception
- Interventions
- Combination Product: Paragard® T380A Intrauterine Copper Contraceptive with New Inserter
- Registration Number
- NCT05309694
- Lead Sponsor
- CooperSurgical Inc.
- 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 reproductive potential.
- 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 copper contraceptive). The study will be conducted in female subjects of child bearing potential.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 119
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1 Paragard® T380A Intrauterine Copper Contraceptive with New Inserter Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
- Primary Outcome Measures
Name Time Method Successful Insertions From enrollment to end of treatment at 3 months The percentage of successful insertions will be calculated by number of subjects with successful insertions relative to the total number of subjects with at least one successful or unsuccessful insertion attempt.
- Secondary Outcome Measures
Name Time Method Pelvic Infections From enrollment to end of treatment at 3 months Frequency of pelvic infections related to IUS insertion and use
IUS Expulsions and Dislocations From enrollment to end of treatment at 3 months Frequency of IUS expulsions (partial or total) and dislocations
Adverse Events related to Procedure From enrollment to end of treatment at 3 months Frequency of AEs related to procedure
Uterine Perforation and IUD Embedment From enrollment to end of treatment at 3 months Frequency of uterine perforation and IUD embedment
Vasovagal Events From enrollment to end of treatment at 3 months Frequency of vasovagal events at the time of insertion
Adverse Events From enrollment to end of treatment at 3 months Frequency of Serious Adverse Events (SAE) and Adverse Events (AE)
Trial Locations
- Locations (8)
Austin Area Ob-Gyn & Fertility
🇺🇸Austin, Texas, United States
Hilltop Obstetrics & Gynecology
🇺🇸Franklin, Ohio, United States
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
Central Austin - Women Partners in Health
🇺🇸Austin, Texas, United States
Valley Ob-Gyn Clinic, PC
🇺🇸Saginaw, Michigan, United States
Seattle Clinical Research Center
🇺🇸Seattle, Washington, United States