EUCTR2007-005080-10-GB进行中（未招募）1 期
Irregular vaginal bleeding with etonorgestrel contraceptive implant - A pilot randomised controlled trial of prophylactic down regulation with a Gonadotrophin releasing hormone analogue prior to implant insertion. - Prophylactic GnRH analogue for contraceptive implant bleeding problems
niversity Hospitals of Leicester NHS Trust0 个研究点目标入组 90 人开始时间: 2007年11月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Women aged 20-40 (most likely to have a baseline regular menstrual cycle)
- •2. Requesting Implanon® for contraception after appropriate counseling and consent
- •3. Willing to follow study criteria and comply with study procedures
- •4. Signed informed consent to participate in study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Contraindications to Implanon®:Pregnancy
- •Undiagnosed vaginal bleeding
- •Severe arterial disease
- •Liver adenoma
- •Active Gestational Trophoblastic disease
- •Sex-steroid dependent cancer
- •Enzyme inducing medication
- •2. Contraindications to GnRHa:Pregnancy
- •Undiagnosed vaginal bleeding
- •Breastfeeding
- •Metabolic bone disease
- •3. Unwilling to keep a menstrual diary
- •4. Unwilling to follow study criteria and comply with study procedures
- •5. Unable to understand patient information leaflet
- •6. Current involvement in other research projects
- •7. Within 6 weeks of termination of pregnancy
研究者
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