Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

• Status: Terminated
• Trial end date: 2018-04-18
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mahidol University
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Gestodene; Megestrol; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Woman age 19-40 yr

• Normal uterus and both adnexae

• BMI < 28.5 kg/m2

• Require contraception with COCs

Exclusion Criteria:

• Pregnancy

• Postartum period within 6 wk

• Smoking

• BP ≥ 140/90 mmHg

• Contraindication to COCs : VTE, cerebrovascular disease, cardiovascular disease, migraine with aura, hepatitis, undiagnosed abnormal uterine bleeding, CA breast, DM with DN/DR

• use of liver-enzyme-inducing drugs, drugs affecting the haemostatic system

• Use contraceptive steroids within 3 months