The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users; a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo
研究概览
简要总结
The purpose of this study is to determine that once-a-month injectable contraceptive( Cyclofem® ) has the effect on treatment of irregular uterine bleeding in implant contraceptive users or not.
详细描述
Stratified randomization Implanon and Jadelle group were done using block randomization. The participants and investigators were blinded to treatment allocation, using drug coding that not revealed until the end of study. Research assistants and nurse who did not have involve in analyses data would follow the recruitment criteria and drug injection follow the code of drug.
All participants were collected demographic data, medical history, obstetrical and gynecological history, bleeding pattern before enrollment. Then physical exam and pelvic examination were performed for all participants. Participants received single dose intramuscular injection of Cyclofem® 0.5 ml or normal saline 0.5 ml as placebo on that day of recruitment to the study. Daily record of bleeding, spotting and side effect was done on record form.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Implant (Jadelle or Implanon) inserted before enrollment with the symptom of bleeding disturbances for eight or more continuous days or a current bleeding-free interval of 15 days or less
- •Regular menstruation at least 1 cycle before the usage of implant contraceptive
- •Willingness to participate in a placebo-controlled study and ability to keep an accurate daily menstrual record
- •No gynecological or serious medical diseases
排除标准
- •Contraindication to estrogen or progesterone use such as
- •breast cancer
- •Liver cancer or tumor
- •Uncontrolled blood pressure (BP ≥160/100 mmHg )
- •History of atherosclerosis, vascular disease and high risk for VIE
- •History of ischemic stroke
- •Coagulopathy
- •Uncontrolled diabetes mellitus and complication
- •Cirrhosis
- •SLE with antiphospholipid positive
- •History of migraine with aura or age of 35 years old or more than with history of migraine non-aura
- •Age of 35 years old or more than with history of smoking more than 15 cigarettes per day
- •Postpartum 6 weeks
- •Plan for surgery procedure that need immobilization after surgery
- •Previous treatment for 3 months before enrollment
- •Allergic to drug component of Cyclofem® ( Medroxyprogesterone acetate , Estradiol cypionate)
研究组 & 干预措施
Cyclofem group
Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose
干预措施: Cyclofem (Drug)
Placebo group
normal saline 0.5 ml IM single dose
干预措施: Cyclofem (Drug)
结局指标
主要结局
Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo
时间窗: 12 weeks
Menstrual record chart was using to record bleeding/spotting days
次要结局
- Number of days that bleeding stopped between Cyclofem® and placebo for the treatment of irregular uterine bleeding in implant contraceptive users(12 weeks)
- Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users(12 weeks)