FemBloc Permanent Contraception Trial

  • STATUS
    Recruiting
  • End date
    Dec 29, 2025
  • participants needed
    50
  • sponsor
    Femasys Inc.
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Updated on 19 February 2024
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Summary

The purpose of this study is to evaluate if changes to the FemBloc Permanent Contraceptive System are effective in increasing reliance (the ability of a woman to be able to depend on FemBloc for contraception once the treatment and confirmation test have been performed), and decreasing pregnancy rate. In addition, the study will compare the FemChec confirmation procedure to that of fluoroscopic HSG, a well-established method of confirmation.

Details
Condition Contraception, Contraception
Age 21years - 45years
Treatment FemBloc
Clinical Study IdentifierNCT04273594
SponsorFemasys Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Female, 21 - 45 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
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)
Allergy to shellfish, betadine or iodinated contrast
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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