ContraceptionBLOCNCT03433911
FemBloc® Permanent Contraception - Early Pivotal Trial
A study testing FemBloc and Laparoscopic bilateral tubal sterilization in people with Contraception, run by Femasys Inc. at 12 sites in United States.
Trial summary
Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study duration will be approximately 65 months. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- FemBloc and Laparoscopic bilateral tubal sterilization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 12 sitesUnited States
- Study dates
- 2 Feb 2018to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 21 - 45 years of age desiring permanent birth control
- Sexually active with male partner
- For FemBloc Arm:
- Regular menstrual cycle for last 3 months or on hormonal contraceptives
- For Control Arm:
- Undergoing planned laparoscopic bilateral tubal sterilization
Who cannot join
- Uncertainty about the desire to end fertility
- Known or suspected pregnancy
- Prior tubal surgery, including sterilization attempt
- Prior endometrial ablation
- Presence, suspicion, or previous history of gynecologic malignancy
- Abnormal uterine bleeding requiring evaluation or treatment
- Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University Hospitals Cleveland Medical Center
Beachwood, Ohio, 44122
New Horizons Clinical Trials
Chandler, Arizona, 85224
Chattanooga Medical Research LLC
Chattanooga, Tennessee, 37404
Women's Health Advantage
Fort Wayne, Indiana, 46825
Rosemark Womencare Specialists
Idaho Falls, Idaho, 83404
Altus Research Inc.
Lake Worth, Florida, 33461
Amy Brenner MD & Associates
Mason, Ohio, 45069
Columbia University Medical Center
New York, New York, 10032
Rutgers, The State University of New Jersey
Newark, New Jersey, 07103
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
University of Utah
Salt Lake City, Utah, 84132
Stanford University
Stanford, California, 94305
About this study
Official title: BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study duration will be approximately 65 months. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.
- Conditions
- Contraception
- Being tested
- FemBloc, Laparoscopic bilateral tubal sterilization
- Keywords
- Permanent contraception, Birth control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemBlocDevice
Treatment with FemBloc for women who desire permanent birth control (female sterilization)
Laparoscopic bilateral tubal sterilizationProcedure or surgery
Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)
| Study group | Role | What they receive |
|---|---|---|
| FemBloc | Experimental | Investigational device and procedure Receives: Device: FemBloc |
| Control | Active comparator | Laparoscopic bilateral tubal sterilization Receives: Procedure: Laparoscopic bilateral tubal sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of short-term and long-term adverse events in each arm
Safety: Incidence of short-term and long-term adverse events in each arm
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start2 Feb 2018
- Primary completion31 Jan 2020
- Study completion10 Feb 2025
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Femasys Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor, Study director, Medical Affairs & Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433911
- Sponsor's protocol ID
- CP-100-007
- Acronym
- BLOC
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2018
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
- ClinicalTrials.gov ID
- NCT03433911
- Acronym / sponsor ID
- BLOC / CP-100-007
- Conditions
- Contraception
- Keywords
- Permanent contraception, Birth control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Femasys Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 15 Feb 2018 (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, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study duration will be approximately 65 months. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FemBloc | Experimental | Device: FemBlocInvestigational device and procedure |
| Control | Active comparator | Procedure: Laparoscopic bilateral tubal sterilizationLaparoscopic bilateral tubal sterilization |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female, 21 - 45 years of age desiring permanent birth control
- Sexually active with male partner
- For FemBloc Arm:
- For Control Arm:
Key exclusion criteria (7 listed)
- Uncertainty about the desire to end fertility
- Known or suspected pregnancy
- Prior tubal surgery, including sterilization attempt
- Prior endometrial ablation
- Presence, suspicion, or previous history of gynecologic malignancy
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 with FemBloc for women who desire permanent birth control (female sterilization) | Device | FemBloc |
| Laparoscopic bilateral tubal sterilizationLaparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization) | Procedure or surgery | Control |
Primary outcome
Incidence of short-term and long-term adverse events in each arm
Time frame: 1-5 years
Safety: Incidence of short-term and long-term adverse events in each arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- FemBloc 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. This study is not recruiting at the moment.
Sponsor study director
Medical Affairs & 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 and Laparoscopic bilateral tubal sterilization 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 27 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of short-term and long-term adverse events in each arm (time frame: 1-5 years). 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 27 Feb 2026.