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

Chulalongkorn University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Uterine Bleeding

Treatments: Drug: Cyclofem

Study type: Interventional

Funder types: Other

Identifiers

NCT03264781

OBCU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Cyclofem group

Experimental group

Description:

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

Treatment:

Drug: Cyclofem

Placebo group

Placebo Comparator group

Description:

normal saline 0.5 ml IM single dose

Treatment:

Drug: Cyclofem