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Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

Sponsor
Mahidol University (Other)
Overall Status
Terminated
CT.gov ID
NCT03531437
Collaborator
(none)
112
Enrollment
2
Arms
25.6
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate
  • Drug: 15 µg ethinylestradiol and 60 µg gestodene
 Phase 4

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
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 Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Apr 18, 2018

Arms and Interventions

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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. D-dimer [12 weeks]

      µg/L

    Secondary Outcome Measures

    1. fibrinogen [12 weeks]

      mg/dL

    2. antithrombin III [12 weeks]

      percent

    3. to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz® [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nalinee Panichyawat, Siriraj hospital, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT03531437
    Other Study ID Numbers:
    • 656/2558 (Si726/2015)
    First Posted:
    May 21, 2018
    Last Update Posted:
    May 21, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Thrombophilia
    Ethinyl Estradiol
    Gestodene
    Estradiol

    Study Results

    No Results Posted as of May 21, 2018