NCT06019533已完成3 期
A Multicentre, Single Arm Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles
Chemo Research2 个研究点 分布在 1 个国家目标入组 1,039 人开始时间: 2023年8月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,039
- 试验地点
- 2
- 主要终点
- Pearl Index
研究概览
简要总结
Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13 cycles.The assessments include (but are not limited to) recording demographic data, pregnancy tests, gynaecological examinations, laboratory tests and a quality of life questionnaire. Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only). The women will be provided with an e-diary app for their smartphone, to record IP use and vaginal bleeding.
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At Visit 1a, subjects must meet ALL of the following criteria:
- •Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
- •Women who either
- •have never used hormonal contraceptives before consent/assent (naïve users), or
- •have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or
- •directly switch from another hormonal contraceptive (switchers).
- •Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent:
- •Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.
排除标准
- •Pregnancy or wish of pregnancy.
- •Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
- •History of infertility.
- •Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
- •Unexplained amenorrhoea.
- •Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.
研究组 & 干预措施
LVDS
Experimental
干预措施: LVDS (Combination Product)
结局指标
主要结局
Pearl Index
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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