What side effects are associated with this type of intervention?

Common treatments for birth control include hormonal contraceptives (pills, patches, rings, injections), intrauterine devices (IUDs), and permanent methods like fallopian tube occlusion. Hormonal contraceptives can cause side effects such as nausea, weight gain, mood changes, and an increased risk of venous thromboembolism. IUDs, particularly those releasing hormones, may lead to menstrual disturbances, cramping, and in rare cases, uterine perforation. Permanent methods like fallopian tube occlusion are generally safe but can involve risks such as infection, bleeding, and damage to surrounding organs during the procedure.

What prior FDA approvals exist?

The FDA has approved various methods for birth control, including hormonal contraceptives like oral pills, patches, and injectables, as well as long-acting reversible contraceptives such as intrauterine devices (IUDs) and subdermal implants. For permanent contraception, methods like tubal ligation have been widely used. The FemBloc Permanent Contraceptive System, which involves fallopian tube occlusion, is similar to the previously approved Essure system, a non-surgical permanent birth control method that also occludes the fallopian tubes to prevent pregnancy. However, Essure was discontinued due to safety concerns. The FemBloc system aims to provide a safer alternative for permanent contraception.

What other types of research exist?

Promising, novel alternatives to the FemBloc Permanent Contraceptive System for birth control in 2024 include the SCu300A intrauterine ball, Nexplanon implant, ulipristal acetate for emergency contraception, levonorgestrel-releasing intrauterine device (LNG-IUD), and etonogestrel subdermal implants.

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Permanent Contraception Device

FemBloc® for Birth Control Confirmation (BLOC Trial)

N/A

Waitlist Available

Research Sponsored by Femasys Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female, 21 - 45 years of age desiring permanent birth control

Be between 18 and 65 years old

Must not have

Prior endometrial ablation

Presence, suspicion, or previous history of gynecologic malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified here but may include discomfort during the procedure and possible allergic reactions in those sensitive to materials used in either FemBloc or imaging techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had surgery on my fallopian tubes, including for sterilization.

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I am experiencing unusual bleeding from my uterus.

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I am scheduled for procedures inside my uterus at the same time as other treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Concordance

Reliance Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FemBlocExperimental Treatment1 Intervention

Investigational device and procedure

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common birth control treatments work through various mechanisms to prevent pregnancy. Hormonal methods, such as oral contraceptives, patches, and rings, primarily prevent ovulation and thicken cervical mucus to block sperm entry. Intrauterine devices (IUDs), both copper and hormonal, create an inhospitable environment for sperm and may prevent fertilization or implantation. Permanent methods like tubal ligation and the FemBloc Permanent Contraceptive System involve occluding the fallopian tubes to block the passage of eggs to the uterus. Understanding these mechanisms is crucial for patients as it helps them choose the most suitable method based on their health, convenience, and long-term reproductive plans.

Reproductive Health Care in Catholic Facilities: A Scoping Review.