Evaluation of the Effectiveness, Safety and Tolerability of the ContraMed VeraCept Intrauterine Copper Contraceptive for Long-Acting Reversible Contraception
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 12
- 主要终点
- The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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);
- •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;
- •Sexually active with a male partner who has not had a vasectomy;
- •Reasonably expect to have to coitus at least once monthly during the study period.
- •Married or in a steady relationship (e.g., 3-6 months);
- •Seeking to avoid pregnancy for the next 12 months;
- •Willing to use the study device as the sole form of contraception;
- •Willing to accept a risk of pregnancy;
- •Normal PAP or ASC-US with negative high risk HPV test result within the appropriate screen timeframe, unless considered at risk;
- •Able and willing to comply with all study tests, procedures, assessment tools and follow-up; and
- •Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI).
排除标准
- •Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle
- •Subject who anticipates separation from her partner for more than 1 cycle within the next 12 months;
- •A previously inserted IUD that has not been removed by the time VeraCept is placed;
- •History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place;
- •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;
- •Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 12 months of study participation;
- •Postpartum, prior to a minimum of 6 weeks or complete uterine involution;
- •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
- •Unexplained abnormal uterine bleeding (suspicious for serious condition), before evaluation; Immediately post-septic abortion or puerperal sepsis;
- •Severely heavy or painful menstrual bleeding;
- •Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically significant abnormal pap smear requiring evaluation or treatment
- •Any history of gestational trophoblastic disease with or without detectable elevated ß-hCG levels, or related malignant disease;
- •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
- •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;
- •Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes), or mucopurulent cervicitis;
- •High risk for STDs (e.g., multiple sexual partners);
- •Known or suspected AIDS;
- •Known intolerance or allergy to nickel or copper, including Wilson's Disease;
- •Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study;
- •Subject had VeraCept placed previously or had 2 attempts at placement;
- •Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
- •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.
研究组 & 干预措施
VeraCept IUD System
All women will receive VeraCept.
干预措施: VeraCept (Drug)
结局指标
主要结局
The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index
时间窗: 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.
次要结局
- VeraCept Placement Success(Visit 1 (Day 1)/ VeraCept Placement)
- Ease of VeraCept Placement(Visit 1 (Day 1)/ VeraCept Placement)
- 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.)