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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. Identifier: NCT03531437
Recruitment Status : Terminated (problem with recruiting participants)
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Information provided by (Responsible Party):
Nalinee Panichyawat, Mahidol University

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

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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

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®

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

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

  2. antithrombin III [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
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
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Responsible Party: Nalinee Panichyawat, Siriraj hospital, Mahidol University 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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Hematologic Diseases
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral