Effect on thrombin generation of oral contraceptives containing drospirenone in women with polycystic ovary syndrome: a prospective, randomized study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250313004

Enrollment

Registered

2025-03-13

Start date

2025-04-01

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, thrombin generation, oral contraceptives PCOS, thrombin generation

Interventions

- Patient will be prescribed estetrol-drospirenone for 12 weeks - Blood for thrombin generation will be drawn at baseline and at 12 weeks,- Patient will be prescribed drospirenone for 12 weeks - Blood

Experimental Drug,Experimental Drug

Estetrol-drospirenone,Drospirenone

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women who are diagnosed PCOS 2. Age 18-40 years 3. BMI 18-35 kg/m2

Exclusion criteria

Exclusion criteria: 1. Contraindicated for hormonal used 2. Medical conditions/ family history of coagulopathy, bleeding disaorders 3. DM, HT, CVD 4. Prior use of exogenous hormones containing estrogen within 3 months 5. Use of anticoagulant 6. Presence/ history of VTE 7. Thyroid dysfunction/ hyperprolactinemia 8. Smoking 9. Pregnancy

Design outcomes

Primary

Measure	Time frame
Thrombin generation 12 weeks Thrombin generation assay	—

Secondary

Measure	Time frame
Bleeding pattern 12 weeks Number of unschedule bleeding,Clinical hyperandrogenism 12 weeks modified Ferriman Gallwey score, acne score,satisfaction 12 weeks questionnaire	—

Countries

Thailand

Contacts

Public ContactPaveenutch Wiwatboworn

Faculty of medicine Siriraj Hospital, Mahidol University

pawenuchy@gmail.com0877955536

Outcome results

None listed

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