FemBloc® Permanent Contraception - Early Pivotal Trial

N/AActive Not RecruitingNCT03433911

Femasys Inc.240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

240

Conditions

Contraception

Interventions

FemBlocDEVICE

Treatment with FemBloc for women who desire permanent birth control (female sterilization)

Laparoscopic bilateral tubal sterilizationPROCEDURE

Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (12)

New Horizons Clinical Trials

Chandler, Arizona, United States

Stanford University

Stanford, California, United States

Altus Research Inc.

Lake Worth, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 1-5 years

Data from ClinicalTrials.gov

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