Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

Phase 4TerminatedNCT03531437

Mahidol University112 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

112

Conditions

Contraception Hypercoagulability

Interventions

1.5 mg estradiol and 2.5 mg nomegestrol acetateDRUG

15 µg ethinylestradiol and 60 µg gestodeneDRUG

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

D-dimer

µg/L

Time frame: 12 weeks

Secondary Outcomes

fibrinogen

mg/dL

Time frame: 12 weeks

antithrombin III

percent

Time frame: 12 weeks

to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®

Time frame: 12 weeks

Data from ClinicalTrials.gov

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