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
About this trial
This is an interventional screening trial for Contraception
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
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
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
Learn more about this trial
Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT
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