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Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531437
Recruitment Status : Terminated (problem with recruiting participants)
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Nalinee Panichyawat, Mahidol University

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE May 21, 2018
Last Update Posted Date May 21, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
D-dimer [ Time Frame: 12 weeks ]
µg/L
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • fibrinogen [ Time Frame: 12 weeks ]
    mg/dL
  • antithrombin III [ Time Frame: 12 weeks ]
    percent
  • to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz® [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Contraception
  • Hypercoagulability
Intervention  ICMJE
  • Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate
    Other Name: Zoely®
  • Drug: 15 µg ethinylestradiol and 60 µg gestodene
    Other Name: Minidoz®
Study Arms  ICMJE
  • 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
    Intervention: Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate
  • 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
    Intervention: Drug: 15 µg ethinylestradiol and 60 µg gestodene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 8, 2018)
112
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 18, 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03531437
Other Study ID Numbers  ICMJE 656/2558 (Si726/2015)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nalinee Panichyawat, Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mahidol University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP