Prospective Multi-Center Trial for FemBloc Permanent Birth Control

Not Applicable

Recruiting

• Conditions: Contraception
• Interventions: Device: FemBloc

• Registration Number: NCT05977751
• Lead Sponsor: Femasys Inc.

Brief Summary

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Detailed Description

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-04
• Study Start: 2023-10-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2029-12
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 573

Inclusion Criteria

• Female, 21 - 50 years of age desiring permanent birth control.
• Sexually active with male partner.
• Regular menstrual cycle for last 3 months or on hormonal contraceptives.

Exclusion Criteria

• Uncertainty about the desire to end fertility.
• Known or suspected pregnancy.
• Prior tubal surgery, including sterilization attempt.
• Presence, suspicion, or previous history of gynecologic malignancy.
• Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.
• Abnormal uterine bleeding requiring evaluation or treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FemBloc	FemBloc	Investigational device and procedure

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate	one (1) year	Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.

Secondary Outcome Measures

Name	Time	Method
Long term Pregnancy Rate	Five (5) years	Number of subjects who were told to rely on FemBloc for birth control that became pregnant after one (1) year through 2-, 3-, 4-, and 5-years.
Reliance Rate	ninety (90) days post treatment	Number of subjects who were told to rely on FemBloc.

Trial Locations

Locations (6)

Stanford University; 🇺🇸 Palo Alto, California, United States

University of California Davis; 🇺🇸 Sacramento, California, United States

Midtown OB GYN North; 🇺🇸 Columbus, Georgia, United States

Seven Hills Women's Health Centers; 🇺🇸 Cincinnati, Ohio, United States

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States