Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

Contraception Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03531437
• Other study ID #: 656/2558 (Si726/2015)
• Status: Terminated
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: April 18, 2018

Study information

• Verified date: May 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: April 18, 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Hypercoagulability
• Thrombophilia

Intervention

Drug:
• 1.5 mg estradiol and 2.5 mg nomegestrol acetate

• 15 µg ethinylestradiol and 60 µg gestodene

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	D-dimer	µg/L	12 weeks
Secondary	fibrinogen	mg/dL	12 weeks
Secondary	antithrombin III	percent	12 weeks
Secondary	to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®		12 weeks