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

NCT ID: NCT03264781

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-12-31

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.

Conditions

Uterine Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cyclofem group

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

Group Type: EXPERIMENTAL

Cyclofem

Intervention Type: DRUG

Intramuscularly injection 0.5 ml of Cyclofem or placebo

Placebo group

normal saline 0.5 ml IM single dose

Group Type: PLACEBO_COMPARATOR

Cyclofem

Intervention Type: DRUG

Intramuscularly injection 0.5 ml of Cyclofem or placebo

Interventions

Cyclofem

Intramuscularly injection 0.5 ml of Cyclofem or placebo

Intervention Type: DRUG

Other Intervention Names

Questionnaire and Menstrual record chart

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nitisa Tapanwong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital

Locations

Chulalongkorn Hospital

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Nitisa Tapanwong, MD

Role: CONTACT

nitisa.tapanwong@gmail.com

066817931684

Facility Contacts

Nitisa Tapanwong, MD

Role: primary

nitisa.tapanwong@gmail.com

Other Identifiers

OBCU

Identifier Type: -

Identifier Source: org_study_id