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 |
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.
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
University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Utah Research is a major component in the life of the U benefiting...
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Los Angeles, California 90095
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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