A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)

PHASE4CompletedINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

March 4, 2022

Primary Completion Date

December 8, 2022

Study Completion Date

December 8, 2022

Conditions
Contraception
Interventions
COMBINATION_PRODUCT

Paragard® 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."

Trial Locations (8)

30363

GYN-CARE Women's Healthcare, Atlanta

33143

South Miami Women's Health, South Miami

45005

Hilltop Obstetrics & Gynecology, Franklin

48602

Valley Ob-Gyn Clinic, PC, Saginaw

78705

Central Austin - Women Partners in Health, Austin

78758

Austin Area Ob-Gyn & Fertility, Austin

80218

Downtown Women's Healthcare, Denver

98105

Seattle Clinical Research Center, Seattle

Sponsors
All Listed Sponsors
lead

CooperSurgical Inc.

INDUSTRY

NCT05309694 - A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive) | Biotech Hunter | Biotech Hunter