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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chulalongkorn University
• Treatments: Contraceptive Agents; CycloProvera; Estradiol; Medroxyprogesterone Acetate

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)