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Recruiting NCT05977751

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

Trial Parameters

Condition Contraception
Sponsor Femasys Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 573
Sex FEMALE
Min Age 21 Years
Max Age 50 Years
Start Date 2023-10-31
Completion 2029-12
Interventions
FemBloc

Brief Summary

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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.

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