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Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

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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

Study Description
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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
Contraception Hypercoagulability 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
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Study Type : Interventional  (Clinical Trial)
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 : March 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : April 18, 2018

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Arms and Interventions
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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 Name: 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 Name: Minidoz®


Outcome Measures
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Primary Outcome Measures :
  1. D-dimer [ Time Frame: 12 weeks ]
    µg/L


Secondary Outcome Measures :
  1. fibrinogen [ Time Frame: 12 weeks ]
    mg/dL

  2. antithrombin III [ Time Frame: 12 weeks ]
    percent

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

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Thrombophilia
Hematologic Diseases
Ethinyl Estradiol
Gestodene
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Progestins