FemBloc® Permanent Contraception - Early Pivotal Trial

Completed · Not applicable

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT03433911

Run by

Femasys Inc.

People needed

240

Starts

2018-02-02

Expected to finish

2025-02-10

Last updated by the study team

2026-02-27

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• New Horizons Clinical Trials — Chandler, Arizona, United States
• Stanford University — Stanford, California, United States
• Altus Research Inc. — Lake Worth, Florida, United States
• Rosemark Womencare Specialists — Idaho Falls, Idaho, United States
• Women's Health Advantage — Fort Wayne, Indiana, United States
• Rutgers, The State University of New Jersey — Newark, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• University Hospitals Cleveland Medical Center — Beachwood, Ohio, United States
• Amy Brenner MD & Associates — Mason, Ohio, United States
• Chattanooga Medical Research LLC — Chattanooga, Tennessee, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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