临床试验/NCT00725413

NCT00725413已完成4 期

A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)

Organon and Co0 个研究点目标入组 210 人开始时间: 2001年11月最近更新: 2022年2月4日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Organon and Co
入组人数: 210
主要终点: Pregnancy

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various countries in order to obtain country-specific data.

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: 18 Years 至 40 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Eligible subjects are healthy premenopausal women requiring a long-term method of contraception, with a body mass index between 18 and 29 kg/m2, who are willing to give voluntary written informed consent. Subjects must have regular cycles with a usual length between 24 and 35 days.

排除标准

•Postmenopause
•Infertile
•Under 18; Over 40

研究组 & 干预措施

Arm 1

Experimental

Healthy premenopausal women requiring a long-term method of contraception

干预措施: etonogestrel implant (Implanon) (Drug)

结局指标

主要结局

Pregnancy

时间窗: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.

(Serious) adverse events

时间窗: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.

次要结局

Acceptability (satisfaction questionnaire)(Every 3 months, for the entire duration of the trial)

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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