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

Sponsor

Chulalongkorn University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03264781

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Bleeding	Drug: Cyclofem	Phase 1/Phase 2

Detailed 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

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyclofem group Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose	Drug: Cyclofem Intramuscularly injection 0.5 ml of Cyclofem or placebo Other Names: Questionnaire and Menstrual record chart
Placebo Comparator: Placebo group normal saline 0.5 ml IM single dose	Drug: Cyclofem Intramuscularly injection 0.5 ml of Cyclofem or placebo Other Names: Questionnaire and Menstrual record chart

Arm

Intervention/Treatment

Experimental: Cyclofem group

Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose

Drug: Cyclofem

Intramuscularly injection 0.5 ml of Cyclofem or placebo

Other Names:

Questionnaire and Menstrual record chart

Placebo Comparator: Placebo group

normal saline 0.5 ml IM single dose

Drug: Cyclofem

Intramuscularly injection 0.5 ml of Cyclofem or placebo

Other Names:

Questionnaire and Menstrual record chart

Outcome Measures

Primary Outcome Measures

Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo [12 weeks]
Menstrual record chart was using to record bleeding/spotting days

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)