FemBloc® for Birth Control Confirmation

(BLOC Trial)

Not currently 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: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method called FemBloc for permanent birth control. The goal is to compare the effectiveness of an ultrasound test, FemChec, with another procedure, fluoro HSG, in confirming the effectiveness of the birth control method. Women with regular menstrual cycles who seek permanent birth control may be suitable candidates. Participants should be sexually active with a male partner and certain about ending fertility. As an unphased trial, this study allows participants to contribute to important research on non-surgical permanent birth control methods.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants can have a regular menstrual cycle or be on hormonal contraceptives, suggesting that continuing hormonal contraceptives might be allowed.

What prior data suggests that the FemBloc device and procedure are safe for birth control confirmation?

Previous studies have shown positive safety results for FemBloc. Over five years, researchers reported no serious safety issues. The most common side effects were minor, such as light bleeding (spotting) and pelvic discomfort, indicating that the treatment is generally easy to handle. These findings suggest that FemBloc is a safe option for those considering this contraceptive method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

FemBloc is unique because it offers a non-surgical, minimally invasive approach to birth control confirmation. Unlike traditional methods like tubal ligation or hormonal options that require surgery or ongoing medication, FemBloc uses an investigational device and procedure to confirm birth control without incisions or long-term hormonal effects. Researchers are excited about this treatment because it has the potential to simplify the process and reduce recovery time, making it a more accessible and convenient option for women seeking permanent birth control confirmation.

What evidence suggests that the FemBloc device is effective for birth control?

Research has shown that FemBloc, the investigational device and procedure under study in this trial, is highly effective as a permanent birth control method. In early studies, none of the participants became pregnant three months after the procedure, a significant improvement over the 6% pregnancy rate with traditional surgical sterilization. Five-year safety data also support its use, demonstrating good results without major safety issues. These findings suggest that FemBloc can be a highly effective and safe choice for those seeking permanent contraception. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women aged 21-45 who want permanent birth control. They must have had a regular menstrual cycle or been on hormonal contraceptives for the last three months, be sexually active with a male partner, and sure about ending their fertility. Women with prior tubal surgeries, abnormal bleeding, shellfish or iodine allergies, uncertainty about not having children, pregnancy, past endometrial ablation or gynecologic cancer cannot join.

Inclusion Criteria

I am sexually active with a male partner.

Regular menstrual cycle for last 3 months or on hormonal contraceptives

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.

Allergy to shellfish, betadine or iodinated contrast

I have or might have had cancer related to female reproductive organs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the FemBloc Permanent Contraceptive procedure and confirmation with FemChec and Fluoro HSG

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the procedure

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• FemBloc

Trial Overview The FemBloc Permanent Contraceptive System is being tested to see if it's an effective method of birth control without surgery. The study will check how well ultrasound compares to fluoroscopic hysterosalpingogram (a type of X-ray) in confirming that the fallopian tubes are blocked after using FemBloc.

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

Depot medroxyprogesterone acetate (DMPA) and medroxyprogesterone acetate/estradiol cypionate (MPA/E(2)C) are highly effective and safe injectable contraceptive options for women, with DMPA notably reducing the risk of endometrial cancer by 80%.

Both contraceptive methods may cause minor side effects, such as menstrual irregularities and amenorrhea with DMPA, highlighting the importance of patient counseling for successful long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current options for injectable contraception in the United States. Kaunitz, AM.[2013]

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]

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 There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

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. 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 ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03433911

FemBloc® Permanent Contraception - Early Pivotal Trial Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

8. 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.