FemBloc® Contraception Pivotal Trial

  • Interventional
  • Recruiting
  • NCT03433911
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
Female

Age Group
21 Years to 45 Years

Accepting Healthy Volunteers?
Accepts Healthy Volunteers

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)
  • Contraception

At a Glance

National Government IDNCT03433911

IRB#IRB18-0015

Lead SponsorFemasys Inc.

Lead PhysicianSadia Haider

Collaborator(s)N/A

EligibilityFemale
21 Years to 45 Years
Recruiting