NCT04457076尚未招募3 期
A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate LevoCept™, a Long-Acting Reversible Intrauterine System for Contraceptive Efficacy, Safety, and Tolerability
Sebela Women's Health Inc.27 个研究点 分布在 1 个国家目标入组 1,525 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,525
- 试验地点
- 27
- 主要终点
- Contraceptive efficacy through 3 years of use as calculated by the Pearl Index
研究概览
简要总结
To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
详细描述
Study Design:
Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 5 years
Number of Subjects:
Approximately 1,525 subjects will be enrolled into the study
Study Population:
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
- — 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed consent/assent and in good general health;
- •History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones or prior to recent pregnancy or spontaneous or induced abortion;
- •Sexually active with a male partner who has not had a vasectomy nor other known fertility problems;
- •Reasonably expect to have coitus at least once monthly during the study period;
- •In a mutually monogamous relationship of at least 3 months duration at time of consent;
- •Seeking to avoid pregnancy for the duration of the study;
- •Willing to use the study drug as the sole form of contraception;
- •Willing to accept a risk of pregnancy;
- •Subjects must be in compliance with cervical cancer screening guidelines per the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without evidence of disease. Subjects who are age 21 to 24 y/o, at time of informed consent, must have a normal Papanicolaou test (Pap), atypical squamous cells of undetermined significance (ASC-US), or low-grade squamous intraepithelial lesion (LSIL). Subjects who are 25 or older at the time of informed consent must have a normal Pap test or an ASC-US result with a negative high-risk human papilloma virus (HPV) test result within the appropriate screen timeframe per ASCCP guidelines, and prior to the study IUD insertion. Alternatively, the subject must have had a colposcopy performed within the appropriate screen timeframe, and prior to the study IUD insertion that showed no evidence of dysplasia requiring treatment per ASCCP guidelines, or treatment was performed and follow-up at least 6 months after the treatment showed no evidence of disease by clinical evaluation;
- •Able and willing to comply with all study tests, procedures, assessment tools (including e-diary) and follow-up;
- •Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI). Unemancipated subjects under 18 years old must provide assent and have written parental/legal guardian consent documented on the consent form consistent with local legal requirements;
- •Plan to reside within a reasonable travel distance of a research site for the duration of the study.
- •Subject agrees not to intentionally self-remove LevoCept
排除标准
- •Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle;
- •Has had any procedure for or causing sterility (e.g. tubal ligation procedure);
- •Subject who anticipates separation from her partner for more than a 6-month period during use of LevoCept;
- •A previously inserted IUD/IUS that has not been removed by the time the study IUS is placed;
- •History of previous IUD/IUS complications, such as perforation, expulsion, or pregnancy with IUD/IUS in place;
- •Pain with current IUD/IUS;
- •Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months and has not had 2 normal menstrual cycles since the last injection;
- •Subject is <4 weeks post-pregnancy (postpartum, spontaneous or induced abortion)
- •Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 60 months of study participation;
- •Exclusively breastfeeding before return of menses; lactating women will be excluded unless they have had 2 normal menstrual periods prior to enrollment;
- •Unexplained abnormal uterine bleeding (suspicious for a serious condition), including bleeding 4 weeks 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 test requiring evaluation or treatment;
- •Any history of gestational trophoblastic disease with or without detectable elevated ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;
- •Any congenital or acquired uterine anomaly that may complicate study drug placement, such as:
- •Submucosal uterine leiomyoma
- •Asherman's syndromes
- •Pedunculated polyps
- •Bicornuate uterus
- •Didelphus or uterine septa
- •Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the investigator, are likely to cause issues during insertion, retention or removal of the IUS;
- •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 drug placement;
- •Untreated or unresolved acute cervicitis or vaginitis;
- •Known or suspected breast cancer or other progestin-sensitive cancer now or in the past;
- •Known acute liver disease or liver tumor;
- •Subjects who have an established immunodeficiency;
- •Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;
- •At high risk for sexually transmitted infections (e.g. multiple sexual partners);
- •Known intolerance or allergy to any components of LevoCept, including intolerance or allergy to levonorgestrel, nickel, titanium, or silicone;
- •Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study. Subject must have waited at least 30 days from exiting their last study prior to informed consent in this study;
- •Subject has previously been enrolled in a VeraCept or LevoCept study (including the current study);
- •Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
- •Any general health, mental 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;
- •Study staff or a member of the immediate family of study staff.
研究组 & 干预措施
LevoCept
Experimental
LevoCept™ Intrauterine Contraceptive
干预措施: LevoCept (Drug)
结局指标
主要结局
Contraceptive efficacy through 3 years of use as calculated by the Pearl Index
时间窗: through 3 years of use
次要结局
- Incidence of AEs and SAEs(5 years)
- Bleeding and spotting patterns(Through year 1)
- Contraceptive efficacy at Years 4 and 5 as calculated by the Pearl Index(Years 4 and 5 and cumulatively through Years 4 and 5)
- Pregnancy percentage(Years 1 through 5)
- Ease of LevoCept placement(Day 1 / LevoCept placement)
- LevoCept Placement success(Day 1 / LevoCept placement)
- Insertion pain assessed immediately after insertion(Day 1, immediately after insertion)
- Cumulative LevoCept continuation rates(Years 1 through 5)
- Cumulative LevoCept expulsion rates(Years 1 through 5)
- Return to Fertility. Only for subjects requesting LevoCept removal to become pregnant.(Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.)
- Release rate of LNG from the IUS and resulting pharmacokinetics of LNG (PK substudy)(Years 1 through 5)
研究者
研究点 (27)
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