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Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

Primary Purpose

Contraception, Hypercoagulability

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
1.5 mg estradiol and 2.5 mg nomegestrol acetate
15 µg ethinylestradiol and 60 µg gestodene
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Contraception

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Zoely

    Minidoz

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    D-dimer
    µg/L

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 11, 2016
    Last Updated
    May 8, 2018
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03531437
    Brief Title
    Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    problem with recruiting participants
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    April 18, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Contraception, Hypercoagulability

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    112 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Zoely
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Minidoz
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    1.5 mg estradiol and 2.5 mg nomegestrol acetate
    Other Intervention Name(s)
    Zoely®
    Intervention Type
    Drug
    Intervention Name(s)
    15 µg ethinylestradiol and 60 µg gestodene
    Other Intervention Name(s)
    Minidoz®
    Primary Outcome Measure Information:
    Title
    D-dimer
    Description
    µg/L
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    fibrinogen
    Description
    mg/dL
    Time Frame
    12 weeks
    Title
    antithrombin III
    Description
    percent
    Time Frame
    12 weeks
    Title
    to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

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