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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03264781
Study type Interventional
Source Chulalongkorn University
Contact Nitisa Tapanwong, MD
Phone 066817931684
Email nitisa.tapanwong@gmail.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 2016
Completion date December 2017

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