Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a Phase III Clinical Study
Up to 250 subjects will be consented, screened and have VeraCept placed, with a goal to have 2240 evaluable cycles at 12 months. It is planned that 225 of the 250 subjects will be within the 18-35 year age range, with a total of 2015 evaluable cycles. The remaining 25 subjects will be within the 35-40 year age range. Follow-up: Physical assessment (office visit) will occur at weeks 6, 13, 26 and 52 after placement, with monthly telephone contact. For those subjects who wish to continue study device use after 12 months, follow-up office visits will occur every 6 months. Additional visits will be conducted if necessary for safety issues. Follow-up after early study device removal: Subjects requesting VeraCept removal to become pregnant will be followed to pregnancy or until the subject changes their mind about trying to get pregnant. All subjects in whom VeraCept is removed prior to 12 months, for any reason, will be required to use an alternative contraceptive for the first two weeks following removal. Progestin-only pills will be provided by the sponsor as a contraceptive option during this time unless the subject has a category 4 condition precluding their use. Study Population: Pre-menopausal women ages 18 - 40, at risk for pregnancy, who are interested in using an intrauterine contraceptive for birth control will be eligible for this study. Subjects must provide written informed consent and meet the study subject selection criteria without any exclusions as outlined in the Clinical Investigation Plan (CIP). Primary Effectiveness Outcome: The primary outcome measure is effectiveness, evaluated as the absence of pregnancy by 12 months, failure will be calculated by the Pearl Index. Safety and Other Outcome Measures: Safety and other outcome measures include: Study Device Placement: * Ease of placement * Placement success Safety: * Serious Adverse Events * Adverse Events Tolerability: * Bleeding and spotting patterns * Discontinuation rate and reasons for discontinuation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
286
IUD placement of VeraCept
Essential Access Health (formerly California Family Health Council)
Burbank, California, United States
Essential Access Health (formerly California Family Health Council)
Los Angeles, California, United States
University of California Davis Health System
Sacramento, California, United States
The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index
The Pearl Index is calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. On-treatment pregnancy is defined as the estimated conception date being on or after the insertion date (must be a successful insertion) and no more than 7 days after the study drug is removed or expelled. One women year is defined as comprising thirteen 28-day cycles. A lower Pearl Index indicates greater contraceptive effectiveness.
Time frame: 12 months
VeraCept Placement Success
The number and percentage of subjects with either a successful or unsuccessful placement will be summarized
Time frame: Visit 1 (Day 1)/ VeraCept Placement
Ease of VeraCept Placement
Ease of placement of the VeraCept was assessed by the clinician immediately following device placement. The clinician rated the ease of placement using the following options: "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard." This rating was based on the clinician's experience during the placement procedure.
Time frame: Visit 1 (Day 1)/ VeraCept Placement
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Bleeding and spotting patterns will be summarized for the first year of treatment (Cycle 1 to Cycle 13) by the mean number of days in each 28-day cycle with bleeding or spotting, bleeding only, and spotting only
Time frame: Cycle 1 to Cycle 13 (post IUD placement). Each cycle is 28 days.
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University of Colorado
Aurora, Colorado, United States
Healthcare Clinical Data, Inc
Miami, Florida, United States
Columbia University Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
...and 2 more locations