What is the mechanism of action of this treatment?

Common birth control treatments include hormonal contraceptives and non-hormonal methods like FemBloc. Hormonal contraceptives, such as combined estrogen-progestin pills, prevent pregnancy by inhibiting ovulation, thickening cervical mucus, and altering the endometrial lining. Non-hormonal methods like FemBloc provide permanent birth control by blocking the fallopian tubes, preventing sperm from reaching the egg. Understanding these mechanisms helps patients choose the most suitable method based on permanence, side effects, and personal health considerations.

What side effects are associated with this type of intervention?

Common side effects of birth control treatments, particularly hormonal methods like oral contraceptives, include nausea, weight gain, mood changes, and breast tenderness. More serious risks include thromboembolism, especially in women with underlying thrombophilic disorders or a history of venous thromboembolic events. Specific to drospirenone-containing oral contraceptives, there is a risk of hyperkalemia, particularly in patients with renal impairment or adrenal insufficiency. Non-hormonal methods like FemBloc, which block the fallopian tubes, may have different side effects, but detailed information on these is less commonly reported.

What prior FDA approvals exist?

The FDA has approved several methods for birth control, including non-surgical, permanent options like the Essure device, which involved placing a coil in the fallopian tubes to create a blockage. However, Essure was discontinued due to safety concerns. Other long-acting reversible contraceptives (LARCs) like intrauterine devices (IUDs) and subdermal implants (e.g., Nexplanon) have also been approved and are widely used. These methods, while not permanent, offer extended protection against pregnancy. FemBloc, currently under trial, represents a novel approach to non-surgical, permanent birth control by blocking the fallopian tubes, similar in intent to Essure but with a different mechanism.

What other types of research exist?

Promising novel alternatives to FemBloc for birth control patients considering treatment in 2024 include: 1) Reversible methods of female or male sterilization, which are still in experimental stages. 2) Long-acting systemic contraceptives and implants, such as etonogestrel and levonorgestrel-releasing implants, which are effective and have been studied for their efficacy. 3) Immunization against implantation or sperm antigens, which is also in experimental stages. 4) Intrauterine devices (IUDs) and injectables, which are currently the most effective available alternatives.

← Back to Search

Procedure

FemBloc for Permanent Birth Control (FINALE Trial)

N/A

Recruiting

Research Sponsored by Femasys Inc.

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five (5) years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing FemBloc, a procedure to block fallopian tubes and prevent pregnancy. It targets women who want a permanent form of birth control. The procedure works by stopping eggs from reaching the uterus. FemBloc is a procedure designed to block fallopian tubes and prevent pregnancy, similar to other permanent contraception methods.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include discomfort during the procedure, potential allergic reactions to materials used in FemBloc, and possible failure leading to unintended pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five (5) years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five (5) years

This trial's timeline: 3 weeks for screening, Varies for treatment, and five (5) years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pregnancy Rate

Secondary study objectives

Long term Pregnancy Rate

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

Do I qualify?Apply below to find out

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 include hormonal contraceptives and non-hormonal methods like FemBloc. Hormonal contraceptives, such as combined estrogen-progestin pills, prevent pregnancy by inhibiting ovulation, thickening cervical mucus, and altering the endometrial lining. Non-hormonal methods like FemBloc provide permanent birth control by blocking the fallopian tubes, preventing sperm from reaching the egg. Understanding these mechanisms helps patients choose the most suitable method based on permanence, side effects, and personal health considerations.

Reproductive Health Care in Catholic Facilities: A Scoping Review.Biphasic versus monophasic oral contraceptives for contraception.