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Tubal Occlusion Device

FemBloc® Permanent Contraceptive System for Birth Control (BLOC Trial)

N/A
Waitlist Available
Research Sponsored by Femasys Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Reasonably certain subject is not pregnant at time of screening and procedure visits
Female, 21 - 45 years of age desiring permanent birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights

BLOC Trial Summary

This trial is testing a new permanent contraceptive system to see if it is safe and effective.

BLOC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The subject is not pregnant at the time of the screening and procedure visits.
Select...
A woman between the ages of 21 and 45 who desires a permanent form of birth control is a good candidate for Essure.
Select...
We agree to use temporary birth control (excluding IUC) until documented occlusion.
Select...
Having sex at least four times a month with a male partner who is not known or suspected to be sterile.
Select...
You are willing to accept the risk of pregnancy while relying on FemBloc for contraception.

BLOC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc treatment procedure
Other outcome measures
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Biopolymer
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Confirmation test

Side effects data

From 2011 Phase 3 trial • 407 Patients • NCT01236768
6%
Cervical dysplasia
5%
Nasopharyngitis
4%
Sinusitis
4%
Sinus Congestion
3%
Nausea
2%
Upper respiratory infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
AG200-15
Levora

BLOC Trial Design

1Treatment groups
Experimental Treatment
Group I: FemBloc® Permanent Contraceptive SystemExperimental Treatment1 Intervention
Treatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FemBloc® Permanent Contraceptive System
2017
N/A
~50

Find a Location

Who is running the clinical trial?

Femasys Inc.Lead Sponsor
5 Previous Clinical Trials
1,072 Total Patients Enrolled
Study DirectorStudy DirectorSponsor Clinical Affairs
1,203 Previous Clinical Trials
489,530 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial open to the public?

"This clinical trial is recruiting 49 individuals seeking permanent birth control who are aged 21 to 45. The participants must abide by the following conditions: be reasonably certain that they are not pregnant at screening and procedure visits, use temporary contraception (except for IUC) until documented occlusion, partake in intercourse with a male partner who does not appear sterile often enough (at least four times per month), and accept pregnancy risks while depending solely on FemBloc as their protection from conception."

Answered by AI

Is enrollment available for this experiment currently?

"Per the information provided on clinicaltrials.gov, this medicine trial is not presently enrolling participants. The study was initially announced in March 2017 and it's last edits were made November 2021; however, 61 other research studies are actively looking for volunteers at present."

Answered by AI

Is this research endeavor recruiting participants older than 35 years old?

"This clinical trial has a relatively narrow age range for participation, with the lower limit set at 21 and the upper one established as 45."

Answered by AI

How many venues are managing this research project?

"This trial is currently recruiting from five different facilities, situated in New york, Chattanooga and Chapel Hill as well as other nearby areas. To reduce the strain of travelling for participants, it is recommended that patients select a location closest to them."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~6 spots leftby Mar 2025