Contraception Clinical Trial
— BLOCOfficial title:
BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Verified date | February 2023 |
Source | Femasys Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 240 |
Est. completion date | January 2025 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 45 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Beachwood | Ohio |
United States | New Horizons Clinical Trials | Chandler | Arizona |
United States | Chattanooga Medical Research LLC | Chattanooga | Tennessee |
United States | Women's Health Advantage | Fort Wayne | Indiana |
United States | Rosemark Womencare Specialists | Idaho Falls | Idaho |
United States | Altus Research Inc. | Lake Worth | Florida |
United States | Amy Brenner MD & Associates | Mason | Ohio |
United States | Columbia University Medical Center | New York | New York |
United States | Rutgers, The State University of New Jersey | Newark | New Jersey |
United States | Wake Research Associates, LLC | Raleigh | North Carolina |
United States | University of Utah | Salt Lake City | Utah |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Femasys Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 1-5 years |
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