A Phase 1/2 interventional study of Cyclofem in Uterine Bleeding, sponsored by Chulalongkorn University. Status unknown at 1 site in Thailand. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by Chulalongkorn University · Phase 1/2, Interventional, and Treatment
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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.
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.
90 studies on the registry are indexed under Uterine Hemorrhage; 13 are open to participants now.
This study's planned enrollment of 44 is below the median of 100 across 62 interventional studies indexed under Uterine Hemorrhage.
Browse Uterine Hemorrhage studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to estrogen or progesterone use such as
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose
Drug: Cyclofem
normal saline 0.5 ml IM single dose
Drug: Cyclofem
Intramuscularly injection 0.5 ml of Cyclofem or placebo
Also known as: Questionnaire and Menstrual record chart
Proportion 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
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Aug 2016, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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