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

Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264781
• Other study ID #: OBCU
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 6, 2017
• Last updated: August 29, 2017
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Chulalongkorn University
• Contact: Nitisa Tapanwong, MD
• Phone: 066817931684
• Email: nitisa.tapanwong[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Uterine Bleeding
• Uterine Hemorrhage

Intervention

Drug:
• Cyclofem
Intramuscularly injection 0.5 ml of Cyclofem or placebo

Locations

Country	Name	City	State
Thailand	Chulalongkorn Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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