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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control
- ClinicalTrials.gov ID
- NCT05977751
- Acronym / sponsor ID
- FINALE / CP-100-009
- Conditions
- Contraception
- Keywords
- Permanent Birth Control, Permanent Contraception, Permanent Sterilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 573 participants (estimated)
- Lead sponsor
- Femasys Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FemBloc | Experimental | Device: FemBlocInvestigational device and procedure |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemBlocTreatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes. | Device | FemBloc |
Primary outcome
Pregnancy Rate
Time frame: one (1) year
Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.
2 secondary outcomes
Reliance Rate
Time frame: ninety (90) days post treatment
Long term Pregnancy Rate
Time frame: Five (5) years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- FemBloc Clinical Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Sponsor study director
Medical Affairs and Clinical Development
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemBloc in people with Contraception, run by Femasys Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (770-500-3910 Ext. 146, StudySupport@Femasys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rate (time frame: one (1) year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.