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