Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03531437

Enrollment

112

Registered

2018-05-21

Start date

2016-03-31

Completion date

2018-04-18

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Hypercoagulability

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

Interventions

DRUG1.5 mg estradiol and 2.5 mg nomegestrol acetate

DRUG15 µg ethinylestradiol and 60 µg gestodene

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
D-dimer	12 weeks	µg/L

Secondary

Measure	Time frame	Description
fibrinogen	12 weeks	mg/dL
antithrombin III	12 weeks	percent
to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®	12 weeks	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026