Status:
UNKNOWN
The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users
Lead Sponsor:
Chulalongkorn University
Conditions:
Uterine Bleeding
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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.
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 un...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03264781
Start Date
August 1 2016
End Date
December 1 2017
Last Update
August 30 2017
Active Locations (1)
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1
Chulalongkorn Hospital
Bangkok, Thailand