Study Details
Testing FINALE a Permanent Birth Control
(IRB#: IRB_00168700)
This study is testing a permanent birth control called FemBloc. The treatment does not require surgery. The study wants to see if FemBloc will help people who do not wish to become pregnant now and in the future. People in the study will have a device with a small amount of the liquid study drug placed in the uterus (the organ between the hip bones where an unborn baby grows). Once the fluid is released the device is removed from the uterus. People in the study will attend both in-person visits at the study clinic and telehealth visits over a technology device such as a computer throughout 5 years. Medical tests will be done during the study to learn and track the health of participants.
- Female Only
- Over 18 years old
- Healthy Volunteers
- In Person
- Paid
Who can participate?
Gender: Female Only
Age: Over 18 years old
Volunteers: Healthy Volunteers
Location: In Person
Inclusion Criteria
- Ages 21 to 50 years old
- Agree to use specific birth control
- At low risk for sexually transmitted infections like HIV
- Not pregnant
- Attend in-person at the study clinic and telehealth visits
Exclusion Criteria
- Prior surgery to prevent pregnancy
- Current or recent pelvic (area below the stomach in between the hip bones) infection within 3 months of participation
- Unresolved cervical (lower part of the uterus) cancer
- Medical treatment that hurts the immune system (helps fight off infections or diseases in the body)
- Prior history of chronic pelvic pain
Will I be paid for my time?
Yes
IRB#: IRB_00168700
PI: Lori Gawron
Department: OBSTETRICS AND GYNECOLOGY
Approval Date: 2023-12-06 07:00:00
Specialties: OB/Gyn, General