FemBloc® Contraception Pivotal Trial
- Interventional
- Recruiting
- NCT03433911
Contact Information
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)
- 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)