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

Phase 1

• Conditions: Uterine Bleeding
• Interventions: Drug: Cyclofem

• Registration Number: NCT03264781
• Lead Sponsor: Chulalongkorn University

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 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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-06-06
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-29
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 44

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclofem group	Cyclofem	Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose
Placebo group	Cyclofem	normal saline 0.5 ml IM single dose

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand