A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- Bioequivalence of Implanon® and Radiopaque Implanon
研究概览
简要总结
The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least 18 but not older than 40 years of age at the time of screening
- •Good physical and mental health
- •Regular cycles with a usual length between 24 and 35 days
- •Body mass index ≥ 18 and ≤ 29
- •Willing to give informed consent in writing
排除标准
- •Contraindications:
- •known or suspected pregnancy
- •active venous thromboembolic disorder (e.g. deep vein thrombosis,pulmonary embolism)
- •presence or history of severe hepatic disease as long as liver function values have not returned to normal
- •malignancy or pre-malignancy, if sex -steroid-influenced
- •undiagnosed vaginal bleeding
- •hypersensitivity to any of the components of Implanon/Radiopaque Implanon
- •Hypertension, i.e. systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg.
- •A history during pregnancy or during previous use of sex steroids of: jaundice and/or severe pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss
- •Present use or use during 2 months prior to the start of Implanon/Radiopaque Implanon of one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin or the herbal remedy St John's wort.
- •Administration of investigational drugs within 2 months prior to the start of Implanon/Radiopaque Implanon
研究组 & 干预措施
Radiopaque Implanon (ro imp)
The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
干预措施: Radiopaque Implanon (Drug)
Implanon (imp)
Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and
2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.
The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after
insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year.
干预措施: Implanon (etonogestrel implant) (Drug)
结局指标
主要结局
Bioequivalence of Implanon® and Radiopaque Implanon
时间窗: 3 years
Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25. Cmax (pg/mL): Peak concentration.
Bioequivalence of Implanon® and Radiopaque Implanon.
时间窗: 3 years
Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25. AUC0-6months (Area under the curve from zero to six months). AUC0-24months (Area under the curve from zero to 24 months). AUC0-36months (Area under the curve from zero to 36 months).
次要结局
未报告次要终点