Contraception
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGVeraCept
IUD placement of VeraCept
Sponsors
Sebela Women's Health Inc.
Premier Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
VeraCept intrauterine contraceptive device
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Between 18-40 years of age at the time of study initiation; 1.1 Enrollment will be targeted for 225 subjects aged 18-35 (for safety and effectiveness analyses) and an additional 25 subjects aged 36-40 (for safety only) (note: all subjects will be included in the analysis for device placement and tolerability); 2. Pre-menopausal, as determined by regular menstrual cycle (28 ± 5 days) for the last 3 months; 2.1 Based on patient history, when not on hormonal contraceptives; 3. Sexually active with a male partner who has not had a vasectomy; 4. Reasonably expect to have to coitus at least once monthly during the study period. 5. Married or in a steady relationship (e.g., 3-6 months); 6. Seeking to avoid pregnancy for the next 12 months; 7. Willing to use the study device as the sole form of contraception; 8. Willing to accept a risk of pregnancy; 9. Normal PAP or ASC-US with negative high risk HPV test result within the appropriate screen timeframe, unless considered at risk; 10. Able and willing to comply with all study tests, procedures, assessment tools and follow-up; and 11. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI).
Exclusion criteria
1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle 2. Subject who anticipates separation from her partner for more than 1 cycle within the next 12 months; 3. A previously inserted IUD that has not been removed by the time VeraCept is placed; 4. History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place; 5. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months; 5.1 Must have had 2 normal menstrual cycles since the last injection; 6. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 12 months of study participation; 7. Postpartum, prior to a minimum of 6 weeks or complete uterine involution; 8. Exclusively breastfeeding before return of menses; Lactating women will be excluded unless they have had two normal menstrual periods. 8.1 Must have had 2 normal spontaneous menstrual cycles since delivery 9. Unexplained abnormal uterine bleeding (suspicious for serious condition), before evaluation; Immediately post-septic abortion or puerperal sepsis; 10. Severely heavy or painful menstrual bleeding; 11. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically significant abnormal pap smear requiring evaluation or treatment 12. Any history of gestational trophoblastic disease with or without detectable elevated ß-hCG levels, or related malignant disease; 13. Known anatomical abnormalities of the uterine cavity that may complicate IUD placement, such as: 13.1 Submucosal uterine leiomyoma 13.2 Asherman's syndrome 13.3 Pedunculated polyps 13.4 Bicornuate uterus 13.5 Didelphus or uterine septa 14. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior trachelectomy or extensive conization that, in the opinion of the investigator would prevent cervical dilation and study device placement; 15. Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes), or mucopurulent cervicitis; 16. High risk for STDs (e.g., multiple sexual partners); 17. Known or suspected AIDS; 18. Known intolerance or allergy to nickel or copper, including Wilson's Disease; 19. Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study; 20. Subject had VeraCept placed previously or had 2 attempts at placement; 21. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit; 22. Any general health or behavioral condition that, in the opinion of the Investigator, could represent an increased risk for the subject or would render the subject less likely to provide the needed study information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VeraCept Placement Success | Visit 1 (Day 1)/ VeraCept Placement | The number and percentage of subjects with either a successful or unsuccessful placement will be summarized |
| Ease of VeraCept Placement | Visit 1 (Day 1)/ 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. |
| Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 1 to Cycle 13 (post IUD placement). Each cycle is 28 days. | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnita L Nelson, MD
University of California, Los Angeles
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VeraCept IUD System All women will receive VeraCept.
VeraCept: IUD placement of VeraCept | 286 |
| Total | 286 |
Baseline characteristics
| Characteristic | VeraCept IUD System |
|---|---|
| Age, Continuous | 27.1 years STANDARD_DEVIATION 5.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 238 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 19 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 182 Participants |
| Sex: Female, Male Female | 286 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 286 |
| other Total, other adverse events | 243 / 286 |
| serious Total, serious adverse events | 4 / 286 |
Outcome results
Primary
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
Population: Evaluation for Pregnancy Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VeraCept IUD System | The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index | All evaluable for pregnancy subjects | 0.53 Pearl Index |
| VeraCept IUD System | The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index | evaluable for pregnancy subjects with at least one live birth | 1.41 Pearl Index |
| VeraCept IUD System | The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index | evaluable for pregnancy subjects never had live birth | 0.00 Pearl Index |
Secondary
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.
Population: The Evaluable for Cycle Control (ECYC) Population includes subjects who provided bleeding-related diary data. The number of participants reported for each cycle reflects the number of ECYC subjects who submitted bleeding-related diary data during that specific cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 13 : spotting only | 1.9 Days | Standard Deviation 2.96 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 1 : bleeding or spotting | 11.2 Days | Standard Deviation 5.83 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 1 : bleeding only | 7.6 Days | Standard Deviation 4.35 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 1 : spotting only | 3.6 Days | Standard Deviation 3.71 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 2 : bleeding or spotting | 8.1 Days | Standard Deviation 4.22 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 2 : bleeding only | 5.8 Days | Standard Deviation 3.29 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 2 : spotting only | 2.2 Days | Standard Deviation 2.61 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 3 : bleeding or spotting | 7.8 Days | Standard Deviation 4.12 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 3 : bleeding only | 5.8 Days | Standard Deviation 3.02 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 3 : spotting only | 2.0 Days | Standard Deviation 2.32 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 4 : bleeding or spotting | 7.2 Days | Standard Deviation 3.62 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 4 : bleeding only | 5.3 Days | Standard Deviation 2.6 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 4 : spotting only | 1.9 Days | Standard Deviation 2.38 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 5 : bleeding or spotting | 7.0 Days | Standard Deviation 3.67 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 5 : bleeding only | 5.3 Days | Standard Deviation 2.7 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 5 : spotting only | 1.8 Days | Standard Deviation 2.61 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 6 : bleeding or spotting | 7.6 Days | Standard Deviation 4.6 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 6 : bleeding only | 5.6 Days | Standard Deviation 3.6 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 6 : spotting only | 2.0 Days | Standard Deviation 2.76 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 7 : bleeding or spotting | 7.1 Days | Standard Deviation 3.81 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 7 : bleeding only | 5.3 Days | Standard Deviation 2.89 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 7 : spotting only | 1.8 Days | Standard Deviation 2.25 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 8 : bleeding or spotting | 6.9 Days | Standard Deviation 3.83 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 8 : bleeding only | 5.3 Days | Standard Deviation 2.94 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 8 : spotting only | 1.6 Days | Standard Deviation 2.03 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 9 : bleeding or spotting | 7.1 Days | Standard Deviation 4 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 9 : bleeding only | 5.3 Days | Standard Deviation 2.84 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 9 : spotting only | 1.7 Days | Standard Deviation 2.39 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 10 : bleeding or spotting | 7.0 Days | Standard Deviation 3.75 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 10 : bleeding only | 5.2 Days | Standard Deviation 2.9 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 10 : spotting only | 1.7 Days | Standard Deviation 2.37 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 11 : bleeding or spotting | 7.0 Days | Standard Deviation 3.57 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 11 : bleeding only | 5.3 Days | Standard Deviation 2.35 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 11 : spotting only | 1.7 Days | Standard Deviation 2.4 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 12 : bleeding or spotting | 7.0 Days | Standard Deviation 4.25 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 12 : bleeding only | 5.4 Days | Standard Deviation 3.25 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 12 : spotting only | 1.7 Days | Standard Deviation 2.35 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 13 : bleeding or spotting | 7.1 Days | Standard Deviation 4.75 |
| VeraCept IUD System | Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle) | Cycle 13 : bleeding only | 5.2 Days | Standard Deviation 3.56 |
Secondary
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
Population: Safety Population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VeraCept IUD System | Ease of VeraCept Placement | Very Easy | 173 Participants |
| VeraCept IUD System | Ease of VeraCept Placement | Easy | 86 Participants |
| VeraCept IUD System | Ease of VeraCept Placement | Neither Easy nor Hard | 11 Participants |
| VeraCept IUD System | Ease of VeraCept Placement | Hard | 8 Participants |
| VeraCept IUD System | Ease of VeraCept Placement | Very Hard | 5 Participants |
Secondary
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
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VeraCept IUD System | VeraCept Placement Success | successfully placed on first attempt | 267 Participants |
| VeraCept IUD System | VeraCept Placement Success | successfully placed on second attempt | 18 Participants |
| VeraCept IUD System | VeraCept Placement Success | not successfully placed | 3 Participants |