Status:
RECRUITING
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Lead Sponsor:
Femasys Inc.
Conditions:
Contraception
Eligibility:
FEMALE
21-50 years
Phase:
NA
Brief Summary
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Detailed Description
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Eligibility Criteria
Inclusion
- Female, 21 - 50 years of age desiring permanent birth control.
- Sexually active with male partner.
- Regular menstrual cycle for last 3 months or on hormonal contraceptives.
Exclusion
- Uncertainty about the desire to end fertility.
- Known or suspected pregnancy.
- Prior tubal surgery, including sterilization attempt.
- Presence, suspicion, or previous history of gynecologic malignancy.
- Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.
- Abnormal uterine bleeding requiring evaluation or treatment.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2031
Estimated Enrollment :
573 Patients enrolled
Trial Details
Trial ID
NCT05977751
Start Date
October 31 2023
End Date
June 1 2031
Last Update
January 28 2025
Active Locations (6)
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1
Stanford University
Palo Alto, California, United States, 94304
2
University of California Davis
Sacramento, California, United States, 95817
3
Midtown OB GYN North
Columbus, Georgia, United States, 31909
4
Maimonides Medical Center
Brooklyn, New York, United States, 11219-2919