FemBloc for Permanent Birth Control

(FINALE Trial)

Recruiting at 6 trial locations

Overseen By Study Director

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Femasys Inc.

Disqualifiers: Pregnancy, Tubal surgery, Gynecologic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

573 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests FemBloc, a new device and procedure, to determine its safety and effectiveness as a permanent birth control option. The main goal is to confirm FemBloc's success through an ultrasound test afterward. Women with regular periods who are certain about ending their fertility might be suitable candidates. Participants should be sexually active with a male partner and have no history of tubal surgeries. As an unphased trial, this study allows participants to contribute to groundbreaking research in permanent birth control options.

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.

What prior data suggests that the FemBloc device and procedure is safe for permanent birth control?

A previous study found that FemBloc showed no serious safety issues over five years. The most common minor side effects included light bleeding and pelvic pain. Another study confirmed that FemBloc had no major negative effects, making it a promising choice for permanent birth control. The procedure also proved effective, with no pregnancies occurring three months after treatment, outperforming traditional surgical sterilization. Overall, these findings suggest that FemBloc is well-tolerated and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional permanent birth control methods, which often involve surgery like tubal ligation or the insertion of devices such as coils, FemBloc offers a non-surgical alternative. This investigational device and procedure use a unique delivery method to block the fallopian tubes, potentially reducing recovery time and eliminating the need for incisions or implants. Researchers are excited about FemBloc because it promises a simpler, less invasive approach to permanent birth control, which could make it more accessible and appealing to many women.

What evidence suggests that FemBloc is effective for permanent birth control?

Research has shown that FemBloc, the investigational device and procedure studied in this trial, is highly effective as a permanent birth control method. In previous studies, no participants became pregnant three months after the procedure, outperforming traditional surgical sterilization. Additionally, it succeeded in 99.6% of cases, working for nearly everyone who underwent it. No serious side effects were reported, making it a safe and effective option for those seeking permanent birth control. ^{3 4 5 6 7}

Who Is on the Research Team?

Study Sponsor

Principal Investigator

Medical Affairs and Clinical Development

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• FemBloc

Trial Overview The 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.

How Is the Trial Designed?

Group I: FemBloc Experimental Treatment 1 Intervention

Investigational device and procedure

Who Is Running the Clinical Trial?

Femasys Inc.

Lead Sponsor

Trials

6

Recruited

1,200+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future developments in hormonal contraception. Johansson, ED.[2005]

New hormonal contraceptive methods, such as the norelgestromin-ethinyl estradiol patch and etonogestrel-ethinyl estradiol vaginal ring, aim to improve compliance and reduce side effects compared to traditional oral contraceptives, which are taken daily.

Despite their different administration methods, these new contraceptives maintain similar efficacy and adverse effect profiles to oral contraceptives, making them viable alternatives for women who may struggle with daily pill adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New hormonal contraceptives: a comprehensive review of the literature. Forinash, AB., Evans, SL.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of injectable hormonal contraception, with special reference to the monthly method. De Aguilar, MA., Altamirano, L., Leon, DA., et al.[2019]

Monthly intramuscular injections of long-acting contraception, like Mesigyna, offer better cycle control compared to other long-acting injectables, making them a promising option for family planning.

Despite the advantages, earlier monthly injectables faced significant issues, and ongoing development of new formulations requires careful evaluation of their safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Existing once-a-month combined injectable contraceptives. Toppozada, MK.[2019]

Citations

1. ir.femasys.com ir.femasys.com/news/news-details/2025/Femasys-Announces-Peer-Reviewed-Publication-of-Positive-Safety-and-Efficacy-Results-from-FemBloc-Permanent-Birth-Control-Clinical-Trials/default.aspx

News Details Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety.

2. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/fembloc-permanent-birth-control-positive-safety-and-efficacy-results/

FemBloc Permanent Birth Control: Positive Safety and ... The trials demonstrated a 0% pregnancy rate among participants three months post-procedure, significantly outperforming traditional surgical sterilization.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03433911

FemBloc® Permanent Contraception - Early Pivotal Trial The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months. Official Title. BLOC: Prospective Multi-Center Office ...

4. fembloc.com fembloc.com/intl/hcp

Healthcare Professionals - FemBloc FemBloc demonstrated a significantly lower pregnancy rate than the historical control. Historic Control: Based on real-world effectiveness of surgical ( ...

5. contemporaryobgyn.net contemporaryobgyn.net/view/fda-grants-ide-approval-for-fembloc-non-surgical-permanent-birth-control

FDA grants IDE approval for FemBloc non-surgical ... Clinical trial data showed a 99.6% procedural success rate and a 0% pregnancy rate, with no serious adverse events reported. FemBloc has already ...

6. fembloc.com fembloc.com/intl/pbc

Permanent Birth Control - FemBloc SAFETY: Through five years, there were no reported serious safety events. The most common non-serious safety events were spotting/bleeding and/or pelvic ...

7. femasys.com femasys.com/birth-control/

Birth Control FemBloc demonstrated a significantly lower pregnancy rate than the historical control (6% pregnancy rate for surgical sterilization)6. SAFETY. Adverse events ...