Status:
ACTIVE_NOT_RECRUITING
FemBloc® Permanent Contraception - Early Pivotal Trial
Lead Sponsor:
Femasys Inc.
Conditions:
Contraception
Eligibility:
FEMALE
21-45 years
Phase:
NA
Brief Summary
Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study dur...
Eligibility Criteria
Inclusion
- Female, 21 - 45 years of age desiring permanent birth control
- Sexually active with male partner
- For FemBloc Arm:
- Regular menstrual cycle for last 3 months or on hormonal contraceptives
- For Control Arm:
- Undergoing planned laparoscopic bilateral tubal sterilization
Exclusion
- Uncertainty about the desire to end fertility
- Known or suspected pregnancy
- Prior tubal surgery, including sterilization attempt
- Prior endometrial ablation
- Presence, suspicion, or previous history of gynecologic malignancy
- Abnormal uterine bleeding requiring evaluation or treatment
- Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03433911
Start Date
February 2 2018
End Date
July 1 2025
Last Update
January 27 2025
Active Locations (12)
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1
New Horizons Clinical Trials
Chandler, Arizona, United States, 85224
2
Stanford University
Stanford, California, United States, 94305
3
Altus Research Inc.
Lake Worth, Florida, United States, 33461
4
Rosemark Womencare Specialists
Idaho Falls, Idaho, United States, 83404