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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
Intramuscularly injection 0.5 ml of Cyclofem or placebo
Chulalongkorn Hospital
Bangkok, Thailand
RECRUITINGProportion of subjects that bleeding stopped after treatment with Cyclofem or placebo
Menstrual record chart was using to record bleeding/spotting days
Time frame: 12 weeks
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
Time frame: 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
Time frame: 12 weeks
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