Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

Mahidol University

Status and phase: Terminated; Phase 4

Conditions: Contraception; Hypercoagulability

Treatments: Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate; Drug: 15 µg ethinylestradiol and 60 µg gestodene

Study type: Interventional

Funder types: Other

Identifiers

NCT03531437

656/2558 (Si726/2015)

Details and patient eligibility

About

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

Full description

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

Enrollment: 112 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Zoely

Active Comparator group

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

Treatment:

Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate

Minidoz

Active Comparator group

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

Treatment:

Drug: 15 µg ethinylestradiol and 60 µg gestodene