FemBloc® Permanent Contraception - Early Pivotal Trial (BLOC)

• ClinicalTrials.gov Identifier: NCT03433911
• Recruitment Status: Active, not recruiting
• First Posted: February 15, 2018
• Last Update Posted: February 17, 2023
• Sponsor: Femasys Inc.
• Information provided by (Responsible Party): Femasys Inc.

Tracking Information

• First Submitted Date: February 1, 2018
• First Posted Date: February 15, 2018
• Last Update Posted Date: February 17, 2023
• Actual Study Start Date: February 2, 2018
• Actual Primary Completion Date: January 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 20, 2021)

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

Original Primary Outcome Measures (submitted: February 8, 2018)

• Confirmed pregnancy rate for subjects told to rely on FemBloc for birth control [ Time Frame: 1 year from being told to rely ]
  Confirmed pregnancy rate for subjects told to rely on FemBloc for birth control
• Reliance rate [ Time Frame: Within 1 year ]
  Number of subjects told to rely divided by number of qualified subjects

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: February 8, 2018)

• Long-term pregnancy rate for subjects told to rely on FemBloc for birth control [ Time Frame: 2-5 years ]
  Long-term pregnancy rate for subjects told to rely on FemBloc for birth control
• 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
• Satisfaction/comfort assessed by questionnaire [ Time Frame: 1-5 years ]
  Satisfaction/comfort assessed by subject questionnaire at various timepoints

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: FemBloc® Permanent Contraception - Early Pivotal Trial
• Official Title: BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
• Brief 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. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Contraception

Intervention

• Device: FemBloc
  Treatment with FemBloc for women who desire permanent birth control (female sterilization)
• Procedure: Laparoscopic bilateral tubal sterilization
  Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)

Study Arms

• Experimental: FemBloc
  Investigational device and procedure
  Intervention: Device: FemBloc
• Active Comparator: Control
  Laparoscopic bilateral tubal sterilization
  Intervention: Procedure: Laparoscopic bilateral tubal sterilization

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 20, 2021): 240
• Original Estimated Enrollment (submitted: February 8, 2018): 975
• Estimated Study Completion Date: January 2025
• Actual Primary Completion Date: January 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03433911
• Other Study ID Numbers: CP-100-007
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Femasys Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Femasys Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Sponsor; Medical Affairs & Clinical Development

• PRS Account: Femasys Inc.
• Verification Date: February 2023