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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

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 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

Trial Design

1Treatment groups
Experimental Treatment
Group I: FemBlocExperimental Treatment1 Intervention
Investigational device and procedure

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.

Find a Location

Who is running the clinical trial?

Femasys Inc.Lead Sponsor
5 Previous Clinical Trials
1,126 Total Patients Enrolled
Study SponsorStudy DirectorMedical Affairs and Clinical Development

Media Library

FemBloc (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05977751 — N/A
Birth Control Research Study Groups: FemBloc
Birth Control Clinical Trial 2023: FemBloc Highlights & Side Effects. Trial Name: NCT05977751 — N/A
FemBloc (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05977751 — N/A
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