Multi-center, Single-arm Study to Assess the Safety, Efficacy, Discontinuation Rate and Pharmacokinetics of the Low-dose Levonorgestrel Intrauterine Contraceptive System (LCS12) in Post-menarcheal Female Adolescents Under 18 Years of Age for 1 Year, and an Optional 2-year Extension Phase
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 304
- 主要终点
- Number of adverse events reported by study subjects
研究概览
简要总结
The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. Approximately 300 generally healthy, post-menarcheal female adolescents with regular menses at the beginning of the study requiring contraception will be enrolled into the study.
Duration of study treatment is approximately 12 months with an option to continue the use of the contraceptive system up to three years if the woman is willing to continue the use after the first 12 months.
The incidence of adverse events over 12 month treatment period will be the main outcome of this study. Also the efficacy (number of pregnancies), discontinuation rate and pharmacokinetics will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The subject has signed and dated the informed consent form (ICF)
- •The subject is female, generally healthy, post-menarcheal, nulliparous or parous, requiring contraception, and is under 18 years of age at the Screening visit
- •The subject has regular menstrual cycles without hormonal contraceptive use (at regular intervals of 21-35 days)
- •In the opinion of the investigator, the subject has general and uterine conditions suitable for the insertion of levonorgestrel intrauterine contraceptive system (LCS12) (uterine sound depth 6-10 cm)
- •Has clinically normal safety laboratory results
- •The subject has a normal or clinically insignificant cervical smear (i.e. one that does not require further follow up according to Bethesda or a comparable system)
- •The subject is willing and able to attend the scheduled study visits and to comply with the study procedures
排除标准
- •Known or suspected pregnancy or is lactating
- •Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1
- •History of ectopic pregnancies
- •Infected abortion or postpartum endometritis less than 3 months before Visit 1
- •Abnormal uterine bleeding of unknown origin
- •Any lower genital tract infection (until successfully treated)
- •Acute or history of recurrent pelvic inflammatory disease
- •Congenital or acquired uterine anomaly
研究组 & 干预措施
Arm 1
干预措施: Skyla (Levonorgestrel, BAY86-5028) (Drug)
结局指标
主要结局
Number of adverse events reported by study subjects
时间窗: 12 months treatment period
Portion of subjects reporting adverse events
时间窗: 12 months treatment period
次要结局
- Bleeding patterns collected from patients' diary(12 months treatment period)
- Pearl index(12 months treatment period)
- Concentration of Levonorgestrel in serum(At 1, 3, 6, 9 or 12 months)
- Concentration of sex hormone binding globulin in serum(At 1, 3, 6, 9 or 12 months)
- Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied)(12 months treatment period)
- Discontinuation rate(12 months treatment period)