Recruiting

FemBloc

Sponsor:

Femasys Inc.

Code:

NCT05977751

Conditions

Contraception

Eligibility Criteria

Sex: Female

Age: 21 - 50

Healthy Volunteers: Accepted

Interventions

FemBloc

Study Details

Brief summary:

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

Conditions

Contraception

Study ID

NCT05977751

Start date

Oct 31, 2023

Status verified date

Mar, 2026

Completion date

Jun, 2031

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 50

Healthy Volunteers: Accepted

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

Enrollment

573 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: FemBloc

Investigational device and procedure

Interventions

FemBloc

Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.

Primary outcome measure

  • Pregnancy Rate [ Time Frame: one (1) year ]

Central Contacts and Locations

Central contacts

Study Director

770-500-3910 Ext. 146StudySupport@Femasys.com

Locations

New Horizons Clinical Trials

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Research Coordinator

480-8496-2236

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Research Coordinator

(650) 497-5175

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Research Coordinator

916-734-6846

Midtown OB GYN North

Recruiting

Columbus, Georgia, United States, 31909

Contacts

Research Coordinator

7063202547

Rosemark WomenCare Specialists

Recruiting

Idaho Falls, Idaho, United States, 83404

Contacts

Research Coordinator

208-557-2924

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219-2919

Contacts

Research Coordinator

718-283-7962

Seven Hills Women's Health Centers

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Research Coordinator

5132903221

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Research Coordinator

801-231-2774

More Information

Sponsor

Femasys Inc.

Last update posted

Mar 3, 2026

Last verified

Mar, 2026

Keywords

  • Permanent Birth Control
  • Permanent Contraception
  • Permanent Sterilization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Femasys Inc. on 2026-03-03.