Contraception
Conditions
Keywords
Permanent contraception, Birth control
Brief summary
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.
Interventions
DEVICEFemBloc
Treatment with FemBloc for women who desire permanent birth control (female sterilization)
PROCEDURELaparoscopic bilateral tubal sterilization
Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)
Sponsors
Femasys Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of short-term and long-term adverse events in each arm | 1-5 years | Safety: Incidence of short-term and long-term adverse events in each arm |
Countries
United States
Contacts
STUDY_DIRECTORSponsor
Medical Affairs & Clinical Development
Outcome results
None listed