Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

Phase 4

Terminated

• Conditions: Contraception; Hypercoagulability
• Interventions: Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate; Drug: 15 µg ethinylestradiol and 60 µg gestodene

• Registration Number: NCT03531437
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed Description

compare the effects of Zoely® and Minidoz® on hemostatic profiles : D-dimer, Antithrombin and fibrinogen

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-01-11
• Study Start: 2016-03
• Primary Completion: 2018-01
• Study Completion: 2018-04-18
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-08
• Last Update Submitted: 2018-05-08
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

• Woman age 19-40 yr
• Normal uterus and both adnexae
• BMI < 28.5 kg/m2
• Require contraception with COCs

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoely	1.5 mg estradiol and 2.5 mg nomegestrol acetate	Monophasic combined oral contraceptive pills 24 white active tablets and 4 yellow inactive tablets each active tablet contains 1.5 mg estradiol and 2.5 mg nomegestrol acetate 3 cycles
Minidoz	15 µg ethinylestradiol and 60 µg gestodene	Monophasic combined oral contraceptive pills 24 active tablets and 4 inactive tablets each active tablet contains ethinylestradiol 15 µg and gestodene 60 µg 3 cycles

Primary Outcome Measures

Name	Time	Method
D-dimer	12 weeks	µg/L

Secondary Outcome Measures

Name	Time	Method
fibrinogen	12 weeks	mg/dL
antithrombin III	12 weeks	percent
to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®	12 weeks