ClinicalTrials.gg
CompletedNCT03433911BLOCUpdated Feb 27, 2026

FemBloc® Permanent Contraception - Early Pivotal Trial

An interventional study of FemBloc and Laparoscopic bilateral tubal sterilization in Contraception, sponsored by Femasys Inc.. Completed at 12 sites in United States. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Femasys Inc. · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Jan 2020, 6 years 9 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Non-randomized
Ages
21 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Contraception

Keywords

  • Permanent contraception
  • Birth control
03

In context

Lead sponsor

Femasys Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female, 21 - 45 years of age desiring permanent
  • 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

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
  • Abnormal uterine bleeding requiring evaluation or treatment
  • Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    FemBloc

    Investigational device and procedure

    Device: FemBloc

  • Active comparator
    Control

    Laparoscopic bilateral tubal sterilization

    Procedure: Laparoscopic bilateral tubal sterilization

Interventions

  • DeviceFemBloc

    Treatment with FemBloc for women who desire permanent birth control (female sterilization)

  • ProcedureLaparoscopic bilateral tubal sterilization

    Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)

06

What researchers measure

Primary outcomes

  1. Incidence of short-term and long-term adverse events in each arm

    Safety: Incidence of short-term and long-term adverse events in each arm

    Time frame: 1-5 years

07

Study locations

12 sites
  • New Horizons Clinical Trials
    Chandler, Arizona 85224, United States
  • Stanford University
    Stanford, California 94305, United States
  • Altus Research Inc.
    Lake Worth, Florida 33461, United States
  • Rosemark Womencare Specialists
    Idaho Falls, Idaho 83404, United States
  • Women's Health Advantage
    Fort Wayne, Indiana 46825, United States
  • Rutgers, The State University of New Jersey
    Newark, New Jersey 07103, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Wake Research Associates, LLC
    Raleigh, North Carolina 27612, United States
  • University Hospitals Cleveland Medical Center
    Beachwood, Ohio 44122, United States
  • Amy Brenner MD & Associates
    Mason, Ohio 45069, United States
  • Chattanooga Medical Research LLC
    Chattanooga, Tennessee 37404, United States
  • University of Utah
    Salt Lake City, Utah 84132, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Jan 2020, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2018
First posted
Feb 15, 2018
StartActual
Feb 2, 2018
Primary completionActual
Jan 31, 2020
CompletionActual
Feb 10, 2025
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03433911
Lead sponsor
Femasys Inc.
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Feb 2, 2018
Primary completion
Jan 31, 2020
Completion
Feb 10, 2025
Last update
Feb 27, 2026

Study contacts

Sponsor
study director · Medical Affairs & Clinical Development

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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