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Comparative effects of 17beta-estradiol/Nomegestrol acetate versus Estetrol/Drospirenone on testosterone level and metabolic parameters in women with polycystic ovary syndrome (PCOS): A randomized controlled non-inferiority trial

Comparative effects of 17beta-estradiol/Nomegestrol acetate versus Estetrol/Drospirenone on testosterone level and metabolic parameters in women with polycystic ovary syndrome (PCOS): A randomized controlled non-inferiority trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260208003
Enrollment
64
Registered
2026-02-08
Start date
2026-01-11
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 Polycystic ovary syndrome Natural estrogen Testosterone

Interventions

Oral contraceptives pills ,Oral contraceptives pills
Active Comparator Drug,Active Comparator Drug
17beta-estradiol/nomegestrol acetate,estetrol/drospirenone

Sponsors

Mookrawee Darachai
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age : women 18 - 40 years old 2. Diagnosis : Newly diagnosed cases of PCOS based on the Rotterdam criteria (at least 2 out of 3 features) as referenced in the International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome 2023 3. BMI 18 - 33 kg/m2 4. Informed Consent : Ability to provide voluntary written informed consent through a formal consent process 5. Language Literacy : Proficient in reading and writing the Thai language

Exclusion criteria

Exclusion criteria: 1. Pre-existing Medical Conditions : History of cardiovascular disease, kidney disease, adrenal gland disorders, liver disease, breast disease, thyroid abnormalities, or autoimmune diseases (Systemic Lupus Erythematosus or Antiphospholipid Syndrome). 2. Psychiatric History : History of severe psychiatric disorders. 3. Thromboembolism : History of Deep Vein Thrombosis or Pulmonary Embolism. 4. Metabolic Disorders : History of Diabetes Mellitus or other metabolic conditions, including the use of medications or dietary supplements that affect glucose and lipid metabolism. 5. Medication History : Use of steroids, hormonal therapy, or hormonal contraceptives within the past 3 months. 6. Surgical History : History of major surgery within the past 6 months. 7. Allergic History : Known history of allergy to the investigational drug(s). 8. Mobility : Patients who are currently immobile or have restricted mobility. 9. Family History of Deep Vein Thrombosis, Pulmonary Embolism, or Thrombophilia. 10. Smokers

Design outcomes

Primary

MeasureTime frame
Testosterone levels 3 months Blood test for free testosterone from calculated free testosterone and free androgen index

Secondary

MeasureTime frame
Metabolic profiles, clinical of hyperandrogegism and quality of life 3 months 1. Blood test for 75 grams oral glucose tolerance test, LDL, HDL, total cholesterol, triglyceride 2. Clinical evaluation by modified Ferriman-Gallwey score and IGA severity scale 3. questionnaires

Countries

Thailand

Contacts

Public ContactMookrawee Darachai

Faculty of Medicine, Khon Kaen University

Mookweechay@gmail.com043348888

Outcome results

None listed

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