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

Primary Purpose

Uterine Bleeding

Status
Unknown status
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Cyclofem
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Bleeding focused on measuring Cyclofem®, Implant, Jadelle, Implanon, irregular uterine bleeding, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Chulalongkorn HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cyclofem group

Placebo group

Arm Description

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

normal saline 0.5 ml IM single dose

Outcomes

Primary Outcome Measures

Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo
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
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
Questionnaire was using to record adverse effect during follow up period

Full Information

First Posted
June 6, 2017
Last Updated
August 29, 2017
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT03264781
Brief Title
The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users
Official Title
The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users; a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Bleeding
Keywords
Cyclofem®, Implant, Jadelle, Implanon, irregular uterine bleeding, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyclofem group
Arm Type
Experimental
Arm Description
Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
normal saline 0.5 ml IM single dose
Intervention Type
Drug
Intervention Name(s)
Cyclofem
Other Intervention Name(s)
Questionnaire and Menstrual record chart
Intervention Description
Intramuscularly injection 0.5 ml of Cyclofem or placebo
Primary Outcome Measure Information:
Title
Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo
Description
Menstrual record chart was using to record bleeding/spotting days
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of days that bleeding stopped between Cyclofem® and placebo for the treatment of irregular uterine bleeding in implant contraceptive users
Description
Menstrual record chart was using to record bleeding/spotting days
Time Frame
12 weeks
Title
Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users
Description
Questionnaire was using to record adverse effect during follow up period
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nitisa Tapanwong, MD
Phone
066817931684
Email
nitisa.tapanwong@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitisa Tapanwong, MD
Organizational Affiliation
Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulalongkorn Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitisa Tapanwong, MD
Email
nitisa.tapanwong@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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