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Venous Thrombosis Risk Markers in Women with Polycystic Ovary Syndrome Using Estetrol/Drospirenone vs Ethinyl Estradiol/Drospirenone: A Randomized Controlled Trial

Venous Thrombosis Risk Markers in Women with Polycystic Ovary Syndrome UsingEstetrol/Drospirenone vs Ethinyl Estradiol/Drospirenone: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260128003
Enrollment
66
Registered
2026-01-28
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Polycystic ovary syndrome which high risk of venous thromboembolism who was treated with combined oral contraceptive pills. Each type of estrogen exhibits distinct characteristics that differentially influence the risk of venous thromboembolism. Polycystic ovary syndrome, Venous thromboembolism, combined oral contraception, type of estrogen

Interventions

Consume combined oral contraception composed of estetrol/Drospirenone for 3 months ,Consume combined oral contraception composed of Ethinylestradiol20mcg/Drospirenone for 3 months
Active Comparator Drug,Active Comparator Drug
Estetrol15mg/Drospirenone,Ethinylestradiol20mcg/Drospirenone

Sponsors

Faculty of medicine prince of songkla university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Patients with polycystic ovary syndrome who diagnose by Rotterdam criteria 2003

Exclusion criteria

Exclusion criteria: 1. Smoker 2. Pregnancy 3. History of hysterectomy or bilateral salpingo-oophorectomy 4. Previous chemotherapy and radiation therapy 5. Recent use of hormonal drugs within the past 3 months (especially for depot medoxyprogesterone [DMPA] within 9 months) 6. Use of medications that reduce the effectiveness of oral contraceptive (such as Rifampicin, Rifabutin, Barbiturates, Carbamazepine, Lamotrigine, Oxacarbazepine, Phenytoin, Primidone, and Topiramate 7. Other ovarian disorders such as premature ovarian failure 8. Abnormal thyroid function 9. Patients who have undergone gastric bypass surgery for obesity 10. Patients receive anticoagulation such as Warfarin 11. Patients receive antiplatelet such as Aspirin 12. Patients who had history or active condition of VTE 13. Patients who had family history of venous thromboembolism 14. Patients who were diagnosed with thrombophilia (e.g., Factor V Leiden, prothrombin gene mutation, antithrombin deficiency, protein C/S deficiency, antiphospholipid syndrome)

Design outcomes

Primary

MeasureTime frame
venous thrombosis marker 3 months value of each markder ,Protein S 3 months measure from serum (value),SHBG 3 months measure from serum (value),Factor VII 3 months measure from serum (value),Factor VIII 3 months measure from serum (value),Factor X 3 months measure from serum (value),D-dimer 3 months measure from serum (value)

Secondary

MeasureTime frame
Vaginal Bleeding pattern each cycle of during consume categorize as schedule bleeding or spottin , Unschedule bleeding or spotting ,Anthropometric 3 months measure as centrimeter

Countries

Thailand

Contacts

Public ContactKrittanai Kuntheekan

Faculty of Medicine, Prince of Songkla University

squitime@gmail.com0924995198

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026