573 Participants Needed

FemBloc for Permanent Birth Control

(FINALE Trial)

Recruiting at 6 trial locations
SD
Overseen ByStudy Director
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Femasys Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing FemBloc, a procedure to block fallopian tubes and prevent pregnancy. It targets women who want a permanent form of birth control. The procedure works by stopping eggs from reaching the uterus. FemBloc is a procedure designed to block fallopian tubes and prevent pregnancy, similar to other permanent contraception methods.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on hormonal contraceptives, it seems you can continue using them.

How is the FemBloc treatment different from other birth control options?

FemBloc is unique because it is designed for permanent birth control, unlike many other contraceptives that are reversible. It offers a novel approach compared to long-term hormonal methods like injectables or implants, which require regular administration or surgical insertion.12345

Research Team

SS

Study Sponsor

Principal Investigator

Medical Affairs and Clinical Development

Eligibility Criteria

This trial is for women aged 21-50 who want permanent birth control. They must have had a regular menstrual cycle in the last three months or be on hormonal contraceptives, and be sexually active with a male partner. Women can't join if they're pregnant, have had previous tubal surgeries, are planning other uterine procedures before confirmation tests, have abnormal bleeding issues, are unsure about ending fertility, or have current or past gynecologic cancers.

Inclusion Criteria

I am sexually active with a male partner.
I am a woman aged 21-50 looking for a permanent birth control method.
Regular menstrual cycle for last 3 months or on hormonal contraceptives

Exclusion Criteria

I have had surgery on my fallopian tubes, including for sterilization.
I have or might have had cancer in my reproductive organs.
I am scheduled for a procedure inside my uterus at the same time as or before my final test.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the FemBloc procedure followed by an ultrasound confirmation test

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Multiple visits (in-person and/or virtual)

Long-term follow-up

Participants are monitored for long-term pregnancy rates

5 years

Treatment Details

Interventions

  • FemBloc
Trial OverviewThe study is testing FemBloc as a method of permanent birth control. It's an international single-arm trial where all participants receive FemBloc followed by ultrasound tests to confirm its effectiveness.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: FemBlocExperimental Treatment1 Intervention
Investigational device and procedure

Find a Clinic Near You

Who Is Running the Clinical Trial?

Femasys Inc.

Lead Sponsor

Trials
6
Recruited
1,200+

Findings from Research

Injectable contraceptives, particularly those containing only progestogen, are effective and safe options for family planning, with no long-term safety issues, although they may cause irregular bleeding that can lead to discontinuation.
Monthly injectable contraceptives that combine progestogens and estrogens not only maintain high efficacy but also improve user acceptability by mimicking natural menstrual cycles, leading to higher continuation rates.
Current status of injectable hormonal contraception, with special reference to the monthly method.De Aguilar, MA., Altamirano, L., Leon, DA., et al.[2019]
Norplant is a highly effective long-term birth control method that releases levonorgestrel steadily for up to five years after being inserted under the skin of the upper arm.
The method has shown excellent user continuation rates and minimal side effects, primarily resulting in irregular menstrual patterns.
Norplant: a new contraceptive.Flattum-Riemers, J.[2013]
The introduction of new contraceptive methods, including long-term options like the transdermal patch and vaginal ring, offers women more effective and convenient choices for preventing pregnancy, with safety profiles comparable to traditional oral contraceptives.
With 60% of unintended pregnancies occurring among women using birth control, the expanded range of contraceptive options is expected to improve user compliance and effectiveness, tailoring solutions to individual needs.
Future developments in hormonal contraception.Johansson, ED.[2005]

References

Current status of injectable hormonal contraception, with special reference to the monthly method. [2019]
Norplant: a new contraceptive. [2013]
Future developments in hormonal contraception. [2005]
New hormonal contraceptives: a comprehensive review of the literature. [2019]
Existing once-a-month combined injectable contraceptives. [2019]