Clinical trial NCT05309694: A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
Official title: A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Contraception
Copper Intrauterine Device
Intrauterine Device
Contraceptive
Birth Control
IUD
IUS
Intrauterine System
Lead sponsor: CooperSurgical Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm and open-label design
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful Insertions
timeFrame: From enrollment to end of treatment at 3 months
Secondary outcomes:
measure: Uterine Perforation and IUD Embedment
timeFrame: From enrollment to end of treatment at 3 months
measure: IUS Expulsions and Dislocations
timeFrame: From enrollment to end of treatment at 3 months
measure: Adverse Events
timeFrame: From enrollment to end of treatment at 3 months
measure: Adverse Events related to Procedure
timeFrame: From enrollment to end of treatment at 3 months
measure: Vasovagal Events
timeFrame: From enrollment to end of treatment at 3 months
measure: Pelvic Infections
timeFrame: From enrollment to end of treatment at 3 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Downtown Women's Healthcare
state: Colorado
city: South Miami
country: United States
facility: South Miami Women's Health
state: Florida
city: Atlanta
country: United States
facility: GYN-CARE Women's Healthcare
state: Georgia
city: Saginaw
country: United States
facility: Valley Ob-Gyn Clinic, PC
state: Michigan
city: Franklin
country: United States
facility: Hilltop Obstetrics & Gynecology
state: Ohio
city: Austin
country: United States
facility: Central Austin - Women Partners in Health
state: Texas
city: Austin
country: United States
facility: Austin Area Ob-Gyn & Fertility
state: Texas
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
Study officials:
affiliation: Seattle Clinical Research Center
name: Robin Kroll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Downtown Women's Healthcare
name: Carol Stamm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Miami Women's Health
name: Joyce Miller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Valley Ob-Gyn Clinic, PC
name: Jacquelyn Robinson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hilltop Obstetrics & Gynecology
name: Ronald Hirth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Area Ob-Gyn & Fertility
name: Mark Akin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Austin - Women Partners in Health
name: Stephanie Reich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GYN-CARE Women's Healthcare
name: Eric L Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: