To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept
Study Design: Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 8 years Number of Subjects: Approximately 1,605 subjects will be enrolled into the study Study Population: Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and who desire a long-term intrauterine contraceptive for birth control will be eligible for this study. Primary Endpoint: The primary endpoint is the contraceptive efficacy through 3 years of use, as assessed by the Pearl Index. Secondary endpoints: Contraceptive Efficacy: * Pearl Index at Years 4, 5, 6, 7 and 8 as well as cumulatively through Years 4, 5, 6, 7 and 8. * Pregnancy percentage by life table analysis (Kaplan-Meier) at Years 1, 2, 3, 4, 5, 6, 7 and 8 * The cumulative Pearl Index for Years 6 to 8 will be calculated as well as the cumulative pregnancy percentage for Years 6 to 8 using a life table analysis (Kaplan-Meier) only for the EP population. Study drug placement: * Ease of VeraCept placement * Placement success Safety: * Serious adverse events (SAEs) * Adverse events (AEs) * Pelvic infection (pelvic inflammatory disease (PID) or endometritis) * Ectopic pregnancies * Uterine perforations * Dysmenorrhea * Abdominal pain * Expulsion rates at Years 1, 2, 3, 4, 5, 6, 7 and 8 Tolerability: * Bleeding and spotting patterns * Insertion pain assessed immediately after insertion * Continuation rates at Years 1, 2, 3, 4, 5, 6, 7 and 8 * Reasons for discontinuation Return to fertility ● Pregnancy rate in subjects who request VeraCept removal specifically to become pregnant. Subjects who desire pregnancy after having VeraCept removed will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,620
VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
Contraceptive Efficacy Through 3 Years of Use
Contraceptive efficacy through 3 years of use, as assessed 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: 3 years
Contraceptive Efficacy at Years 4, 5, 6, 7 and 8
Pearl Index will be calculated for Years 4, 5, 6, 7, and 8 as well as cumulatively through Years 4, 5, 6, 7, and 8
Time frame: Years 4, 5, 6, 7, and 8 and cumulatively through Years 4, 5, 6, 7, and 8
Cumulative Pregnancy Percentage
A life table analysis (using Kaplan-Meier) of pregnancies will be performed for the EP population to present the cumulative pregnancy percentage
Time frame: Years 1 through 3
Ease of VeraCept Placement
Ease of VeraCept placement will be summarized for the ITT population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard). (First Attempt)
Time frame: Visit 1 (Day 1) / VeraCept placement
VeraCept Placement Success
The number and percentage of subjects with either a successful or unsuccessful placement will be summarized for the ITT
Time frame: Visit 1 (Day 1) / VeraCept placement
Bleeding and Spotting Patterns
Bleeding and spotting patterns will be summarized for the first year of treatment by the number of days in each 28-day cycle with bleeding or spotting, bleeding only, and spotting only
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MomDoc Women's Health Research
Scottsdale, Arizona, United States
Copperstate OB/GYN Associates
Tucson, Arizona, United States
Essential Access Health
Berkeley, California, United States
Essential Access Health
Los Angeles, California, United States
Empire Clinical Research
Pomona, California, United States
University of California, Davis Health System
Sacramento, California, United States
M3 Wake Research (formerly Women's Health Care Research)
San Diego, California, United States
M3 Wake Research (formerly Medical Center for Clinical Research)
San Diego, California, United States
Stanford University, Medical Center, Obstetrics and Gynecolocy
Stanford, California, United States
Velocity Clinical Research (formerly Downtown Women's Health Care)
Englewood, Colorado, United States
...and 31 more locations
Time frame: Through year 1
Insertion Pain Assessed Immediately After Insertion (First Attempt)
Insertion pain summarized for subjects at first attempt as reported by the subjects
Time frame: Visit 1 (Day 1), immediately after insertion
Cumulative VeraCept Discontinuation Rates
Cumulative VeraCept discontinuation rates will be summarized using Kaplan-Meier methods for the Safety population.
Time frame: Years 1 through 3
Cumulative VeraCept Expulsion Rates
Cumulative VeraCept expulsion rates will be summarized using Kaplan-Meier methods for the Safety population.
Time frame: Years 1 through 3
Return to Fertility. Only for Subjects Requesting VeraCept Removal to Become Pregnant.
The number and percentage of subjects with each return to fertility response will be summarized for the Safety population.
Time frame: Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.
Safety Adverse Events of Special Interest: Pelvic Infection (PID or Endometriosis), Uterine Perforations, and Abdominal Pain
Time frame: 3 years