Contraception
Conditions
Keywords
Contraception, Copper Intrauterine Device, Intrauterine Device, Contraceptive, Birth Control, IUD, IUS, Intrauterine System
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.
Interventions
COMBINATION_PRODUCTParagard® T380A Intrauterine Copper Contraceptive with New Inserter
Paragard® IUS with Investigational Inserter combines the current insertion tube and white rod to form a new pre-assembled inserter device that supports a single hand operation. The device is used to pass the IUS through the cervical canal and into the uterine cavity and facilitates insertion of the T shaped Paragard® IUS implant into the uterus.
Sponsors
CooperSurgical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single arm and open-label design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall 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. A successful insertion includes participants with at least one successful insertion attempt with a maximum of two attempts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vasovagal Events | From enrollment to end of treatment at 3 months | Frequency of vasovagal events at the time of insertion |
| Number of Participants With Adverse Events Related to Procedure | From enrollment to end of treatment at 3 months | Frequency of AEs related to procedure |
| Number of Participants With Pelvic Infections | From enrollment to end of treatment at 3 months | Frequency of pelvic infections related to IUS insertion and use |
| Number of Participants With Uterine Perforation and IUD Embedment | From enrollment to end of treatment at 3 months | Frequency of uterine perforation and IUD embedment |
| Number of Participants With IUS Expulsions and Dislocations | From enrollment to end of treatment at 3 months | Frequency of IUS expulsions (partial or total) and dislocations |
| Number of Participants With Adverse Events | From enrollment to end of treatment at 3 months | Frequency of Serious Adverse Events (SAE) and Adverse Events (AE) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobin Kroll, MD
Seattle Clinical Research Center
PRINCIPAL_INVESTIGATORCarol Stamm, MD
Downtown Women's Healthcare
PRINCIPAL_INVESTIGATORJoyce Miller, MD
South Miami Women's Health
PRINCIPAL_INVESTIGATORJacquelyn Robinson, MD
Valley Ob-Gyn Clinic, PC
PRINCIPAL_INVESTIGATORRonald Hirth, MD
Hilltop Obstetrics & Gynecology
PRINCIPAL_INVESTIGATORMark Akin, MD
Austin Area Ob-Gyn & Fertility
PRINCIPAL_INVESTIGATORStephanie Reich, MD
Central Austin - Women Partners in Health
PRINCIPAL_INVESTIGATOREric L Brown, MD
GYN-CARE Women's Healthcare
Participant flow
Recruitment details
A total of 131 participants were screened, and 119 were enrolled. Of the 119 participants enrolled, 117 underwent up to two placement attempts of the T380A intrauterine copper contraceptive device using the novel inserter.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.0 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Parity Non-Parous | 64 Participants |
| Parity Parous | 53 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 89 Participants |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 117 |
| other Total, other adverse events | 44 / 117 |
| serious Total, serious adverse events | 2 / 117 |
Outcome results
None listed