FemBloc® for Birth Control Confirmation

(BLOC 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: Unknown

Duration: 8-12 weeks

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the FemBloc Permanent Contraceptive System and compare two methods (ultrasound and fluoroscopic imaging) for confirming that the fallopian tubes are successfully blocked.

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.

How does the FemBloc treatment for birth control differ from other treatments?

The FemBloc treatment is unique because it is a non-surgical, non-hormonal method for permanent birth control, unlike many other options that involve hormones or surgical procedures. ^{1 2 3 4 5}

Eligibility Criteria

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.

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

Allergy to shellfish, betadine or iodinated contrast

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Contraception in the adolescent: an update. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Female condom launched in UK. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

New hormonal contraceptives: a comprehensive review of the literature. [2019]

5. England pubmed.ncbi.nlm.nih.gov

New condoms for men and women, diaphragms, cervical caps, and spermicides: overcoming barriers to barriers and spermicides. [2018]