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

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

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.

Study Overview

• Status: Unknown
• Conditions: Uterine Bleeding
• Intervention / Treatment: Drug: Cyclofem

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nitisa Tapanwong, MD; Phone Number: 066817931684; Email: nitisa.tapanwong@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Chulalongkorn Hospital
    • Contact: Nitisa Tapanwong, MD; Email: nitisa.tapanwong@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo	Menstrual record chart was using to record bleeding/spotting days	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12 weeks

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Nitisa Tapanwong, MD, Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: randomized controlled trial; Implant; Jadelle; Implanon; Cyclofem®; irregular uterine bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; CycloProvera
• Other Study ID Numbers: OBCU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No