The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users; a Randomized Controlled Trial

Conditions
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Uterine Bleeding

Intervention / Treatment
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* Drug: Cyclofem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclofem group<br>Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose | Drug: Cyclofem<br>* Intramuscularly injection 0.5 ml of Cyclofem or placebo<br>* Other names: Questionnaire and Menstrual record chart;|
| Placebo Comparator: Placebo group<br>normal saline 0.5 ml IM single dose | Drug: Cyclofem<br>* Intramuscularly injection 0.5 ml of Cyclofem or placebo<br>* Other names: Questionnaire and Menstrual record chart;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo | Menstrual record chart was using to record bleeding/spotting days | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days that bleeding stopped between Cyclofem® and placebo for the treatment of irregular uterine bleeding in implant contraceptive users | Menstrual record chart was using to record bleeding/spotting days | 12 weeks | 
| Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users | Questionnaire was using to record adverse effect during follow up period | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclofem®, Implant, Jadelle, Implanon, irregular uterine bleeding, randomized controlled trial