ContraceptionFINALENCT05977751
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
A study testing FemBloc in people with Contraception, run by Femasys Inc. at 12 sites in United States.
Trial summary
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- FemBloc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 573 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 Oct 2023to Jun 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219-2919
Research Coordinator, 718-283-7962, NRobins@maimo.org
- Recruiting
New Horizons Clinical Trials
Chandler, Arizona, 85224
Research Coordinator, 480-496-2236, sflores@womenshealthaz.com
- Recruiting
Chattanooga Medical Research LLC
Chattanooga, Tennessee, 37412
Research Coordinator, 423-648-7794, cbryars@chattmedresearch.com
- Recruiting
Seven Hills Women's Health Centers
Cincinnati, Ohio, 45242
Research Coordinator, 513-290-3221, btillman.shcrg@gmail.com
- Recruiting
Midtown OB GYN North
Columbus, Georgia, 31909
Research Coordinator, 706-320-2547, rebeccaw@midtownob.com
- Recruiting
Rosemark WomenCare Specialists
Idaho Falls, Idaho, 83404
Research Coordinator, 208-557-2924, nramirez@rosemark.net
- Recruiting
Atrium Health Navicent
Macon, Georgia, 31201
Research Coordinator, 478-633-1522, Jennifer.Crawford3@Advocatehealth.org
- Recruiting
Columbia University Medical Center/NYPH
New York, New York, 10032
Research Coordinator, 212-305-9672, na2678@cumc.columbia.edu
- Recruiting
Stanford University
Palo Alto, California, 94304
Research Coordinator, 650-497-5175, mrodrig@stanford.edu
- Recruiting
University of California Davis
Sacramento, California, 95817
Research Coordinator, 916-734-6846, obgyncrcs@health.ucdavis.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Research Coordinator, 801-231-2774, amy.orr@hsc.utah.edu
- Recruiting
Baylor Scott & White Research Institute
Temple, Texas, 76508
Research Coordinator, 254-724-7727, Michelle.Vanecek@BSWHealth.org
About this study
Official title: FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Read the detailed description
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
- Conditions
- Contraception
- Being tested
- FemBloc
- Keywords
- Permanent Birth Control, Permanent Contraception, Permanent Sterilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemBlocDevice
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
| Study group | Role | What they receive |
|---|---|---|
| FemBloc | Experimental | Investigational device and procedure Receives: Device: FemBloc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.
Measured: one (1) year
Secondary outcomes (2)
Reliance Rate
Number of subjects who were told to rely on FemBloc.
Measured: ninety (90) days post treatment
Long term Pregnancy Rate
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.
Measured: Five (5) years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start31 Oct 2023
- Primary completionDec 2029 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 573 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Femasys Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Sponsor, Study director, Medical Affairs and Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977751
- Sponsor's protocol ID
- CP-100-009
- Acronym
- FINALE
- Status last verified
- Mar 2026
- First submitted
- 27 Jul 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes