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FemBloc® Contraception Pivotal Trial (BLOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03433911
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Femasys Inc.

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.

Condition or disease Intervention/treatment Phase
Contraception Device: FemBloc Procedure: Laparoscopic bilateral tubal sterilization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 975 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FemBloc
Investigational device and procedure
Device: FemBloc
Treatment with FemBloc for women who desire permanent birth control (female sterilization)

Active Comparator: Control
Laparoscopic bilateral tubal sterilization
Procedure: Laparoscopic bilateral tubal sterilization
Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)




Primary Outcome Measures :
  1. 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

  2. Reliance rate [ Time Frame: Within 1 year ]
    Number of subjects told to rely divided by number of qualified subjects


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Satisfaction/comfort assessed by questionnaire [ Time Frame: 1-5 years ]
    Satisfaction/comfort assessed by subject questionnaire at various timepoints



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433911


Contacts
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Contact: Study Director 770-500-3910 ext 146 Studysupport@femasys.com

Locations
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Sponsors and Collaborators
Femasys Inc.
Investigators
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Study Director: Sponsor Medical Affairs & Clinical Development

Additional Information:
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Responsible Party: Femasys Inc.
ClinicalTrials.gov Identifier: NCT03433911    
Other Study ID Numbers: CP-100-007
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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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
Keywords provided by Femasys Inc.:
Permanent contraception
Birth control