Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

Comparison of Coagulation Profiles in Oral Contraceptive Pills Users Between 1.5 mg Estradiol/2.5 mg Nomegestrol Acetate (Zoely) and 15 mcg Ethinylestradiol/60 mcg Gestodene (Minidoz): A Randomized Control Trial

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

Study Overview

• Status: Terminated
• Conditions: Contraception; Hypercoagulability
• Intervention / Treatment: Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate; Drug: 15 µg ethinylestradiol and 60 µg gestodene

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zoely; 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	Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate; Other Names: Zoely®
Active Comparator: Minidoz; 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	Drug: 15 µg ethinylestradiol and 60 µg gestodene; Other Names: Minidoz®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
D-dimer	µg/L	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): April 18, 2018

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Thrombophilia; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Estradiol; Ethinyl Estradiol; Gestodene
• Other Study ID Numbers: 656/2558 (Si726/2015)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided