FemBloc vs Laparoscopic Sterilization for Birth Control

(BLOC Trial)

Not currently recruiting at 14 trial locations

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Femasys Inc.

Disqualifiers: Pregnancy, Prior tubal surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods of providing permanent birth control for women: FemBloc, a non-surgical procedure, and laparoscopic bilateral tubal sterilization, a surgical procedure that closes the fallopian tubes. Researchers aim to compare the effectiveness and safety of FemBloc with the traditional surgical method. Women aged 21 to 45 who are sexually active and seek permanent birth control may qualify. Participants must have regular menstrual cycles or use hormonal contraceptives if considering FemBloc, or plan a laparoscopic sterilization if choosing the control group. As an unphased study, this trial explores innovative birth control methods and contributes to advancing women's healthcare options.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on hormonal contraceptives, you may continue them if you are in the FemBloc group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that FemBloc, a new birth control method, offers promising safety results. In earlier studies, FemBloc achieved a 0% pregnancy rate three months post-procedure, outperforming traditional methods. Importantly, trials found side effects similar to those of other intrauterine procedures, with no ongoing safety concerns for up to five years. This suggests that FemBloc is well-tolerated and safe for long-term use. It is important to consult a healthcare professional to understand what these findings could mean for individual circumstances. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

FemBloc is unique because it offers a non-surgical approach to permanent birth control, unlike the standard laparoscopic bilateral tubal sterilization, which requires surgery. FemBloc uses an investigational device to block the fallopian tubes, potentially making it less invasive and quicker to recover from compared to traditional methods. Researchers are excited about FemBloc because it could provide a simpler, less risky option for women seeking permanent contraception.

What evidence suggests that this trial's treatments could be effective for birth control?

This trial will compare FemBloc, an investigational device and procedure, with Laparoscopic Bilateral Tubal Sterilization for birth control. Studies have shown that FemBloc is highly effective, with no pregnancies reported in participants three months post-procedure. This surpasses traditional surgical methods. Additional research supports its effectiveness and safety for over five years. In fact, clinical trials have demonstrated it to be 100% effective. These results suggest FemBloc could serve as a reliable non-surgical option for permanent birth control. ^{1 2 3 4 6}

Who Is on the Research Team?

Sponsor

Principal Investigator

Medical Affairs & Clinical Development

Are You a Good Fit for This Trial?

This trial is for sexually active women aged 21-45 who want permanent birth control. They must have a regular menstrual cycle or be on hormonal contraceptives and are planning to undergo laparoscopic tubal sterilization. Women unsure about ending fertility, with abnormal bleeding, gynecologic cancer history, pregnancy, or previous tubal surgery can't join.

Inclusion Criteria

Regular menstrual cycle for last 3 months or on hormonal contraceptives

I am planning to have a laparoscopic procedure to prevent pregnancy.

I am a woman aged 21-45 and want permanent birth control.

Exclusion Criteria

I have had a procedure to remove the lining of my uterus.

I am unsure about wanting to have children in the future.

Known or suspected pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either FemBloc or laparoscopic bilateral tubal sterilization

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-5 years

What Are the Treatments Tested in This Trial?

Interventions

• FemBloc
• Laparoscopic Bilateral Tubal Sterilization

Trial Overview The study compares FemBloc (a new method of permanent contraception) with the standard procedure of laparoscopic bilateral tubal sterilization. It's an international study where participants choose their treatment without being randomly assigned and will be followed up for over five years.

How Is the Trial Designed?

Group I: FemBloc Experimental Treatment 1 Intervention

Investigational device and procedure

Group II: Control Active Control 1 Intervention

Laparoscopic bilateral tubal sterilization

Who Is Running the Clinical Trial?

Femasys Inc.

Lead Sponsor

Trials

6

Recruited

1,200+

Citations

1. 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.

2. 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.

3. 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 ( ...

4. 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.

5. trial.medpath.com trial.medpath.com/news/5b914329b2386a92/fembloc-non-surgical-birth-control-shows-100-effectiveness-in-clinical-trials-with-five-year-safety-data

FemBloc Non-Surgical Birth Control Shows 100 ... - MedPath FemBloc Non-Surgical Birth Control Shows 100% Effectiveness in Clinical Trials with Five-Year Safety Data.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05977751

Prospective Multi-Center Trial for FemBloc Permanent Birth ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.