FemBloc® Permanent Contraception - Early Pivotal Trial
United States240 participantsStarted 2018-02-02
Plain-language 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 duration will be approximately 65 months. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.
Who can participate
Age range21 Years – 45 Years
SexFEMALE
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Inclusion Criteria:
* 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 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)
What they're measuring
1
Incidence of short-term and long-term adverse events in each arm