FemBloc® Contraception Pivotal Trial



Status:Recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:21 - 45
Updated:11/17/2018
Start Date:January 30, 2018
End Date:March 2024
Contact:Study Director
Email:Studysupport@femasys.com
Phone:770-500-3910

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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.


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)
We found this trial at
20
sites
Wellington, Florida 33470
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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750 Hammond Drive Northeast
Atlanta, Georgia 30342
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11100 Euclid Avenue
Beachwood, Ohio 44122
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Chattanooga, Tennessee 37404
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Fort Worth, Texas 76104
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Houston, TX
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Idaho Falls, Idaho 83404
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Las Vegas, Nevada 89106
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6413 Thornberry Court
Mason, Ohio 45040
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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195 University Avenue
Newark, New Jersey 07102
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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San Diego, California 92108
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Stamford, Connecticut 06904
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Tucson, Arizona 85721
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