Clinical trial NCT03264781: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Uterine Bleeding
Keywords: Cyclofem®
Implant
Jadelle
Implanon
irregular uterine bleeding
randomized controlled trial
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of days that bleeding stopped between Cyclofem® and placebo for the treatment of irregular uterine bleeding in implant contraceptive users
timeFrame: 12 weeks
measure: Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital
name: Nitisa Tapanwong, MD
role: PRINCIPAL_INVESTIGATOR
References: