NCT03074045已完成3 期
Multi-center, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 16 μg LNG/Day Initial in Vitro Release Rate (LCS16) in Comparison to a Combined Oral Contraceptive (COC) Containing 30 μg Ethinyl Estradiol and 3 mg Drospirenone (Yarina®) in Young Nulliparous and Parous Women (18 - 29 Years) Over 12 Months of Use (With an Option for Extended Use of LCS16 for up to 5 Years)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 145
- 试验地点
- 9
- 主要终点
- Overall satisfaction rate
研究概览
简要总结
To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject has signed and dated the Informed Consent Form (ICF).
- •The subject is healthy when requesting contraception.
- •The subject is between 18 - 29 years of age (inclusive) at the time of signing the ICF.
- •The subject has normal or clinically insignificant cervical smear for oncocytology (i.e. Pap test) not requiring further follow up (a cervical smear has to be taken at the Screening Visit [Visit 1] or a normal result has to have been documented within the previous 6 months).
- •The subject has a history of regular (i.e., endogenous cyclicity without hormonal contraceptive use) cyclic menstrual periods (length of cycle 21 - 35 days), as confirmed by the subject.
- •The subject is willing and able to attend the scheduled study visits and to comply with the study procedures.
排除标准
- •Pregnancy or current lactation (less than 6 weeks postpartum or since abortion before the Screening Visit)
- •Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit.
- •Chronic, daily use of drugs that may increase serum potassium levels.
- •Undiagnosed abnormal genital bleeding.
- •Acute cervicitis or vaginitis (until successfully treated).
- •Lower urinary tract infection (until successfully treated).
- •Acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections.
- •Congenital or acquired uterine anomaly including fibroids, in the opinion of the investigator, which would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity).
- •Cervical neoplasia, uterine or cervical malignancy, or sex hormone-dependent tumors.
- •History of migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.
研究组 & 干预措施
Reference
Active Comparator
COC (Yarina)
干预措施: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131) (Drug)
Test
Experimental
LCS16 (Low-dose LNG IUS)
干预措施: Levonorgestrel (Kyleena, BAY86-5028) (Drug)
结局指标
主要结局
Overall satisfaction rate
时间窗: 12 months
5-point Likert item 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied
次要结局
- Number of adverse events(Up to 5 years)
- Bleeding pattern(Up to 12 months)
- User satisfaction and bleeding questionnaire(Up to 12 months)
- Discontinuation rates(Up to 5 years)
研究者
研究点 (9)
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