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The Comparison of Contraceptive pills containing Estetrol/Drospirenone versus Ethinyl Estradiol/Drospirenone in effects on Blood sugar in PCOS women

Exploring the Impact of Combined Oral Contraceptives: Estetrol/Drospirenone vs. Ethinyl Estradiol/Drospirenone on Glucose Tolerance in Polycystic Ovarian Syndrome- An Open-label Crossover Study - NIL

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060847
Enrollment
66
Registered
2023-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

Intervention1: Estetrol/Drospirenone (NEXTSTELLIS): A novel form of combined oral contraception contains 15 mg of estetrol (E4) and 3 mg of drospirenone (DRSP) for 3 months then do not receive any co

Sponsors

Faculty of Medicine Research Scholarship, Prince of Songkhla university
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A diagnosis of PCOS according to the modified 2003 Rotterdam diagnostic criteria

Exclusion criteria

Exclusion criteria: -Patients with contraindications to the use of COCs, according to MEC categories 3 and 4. -Smoker -Pregnancy -History of hysterectomy or bilateral salpingo-oophorectomy -Previous chemotherapy or radiation therapy -Recent use of hormonal drugs within the past 2 months -Use of medications that reduce the effectiveness of oral contraceptives (such as Rifampicin, Rifabutin, Barbiturates, Carbamazepine, Lamotrigine, Oxcarbazepine, Phenytoin, Primidone, and Topiramate) -Abnormalities of the pituitary gland (including hyperprolactinemia and adenoma) -Other ovarian disorders such as premature ovarian failure -Diabetes -Abnormal thyroid function -Patients who have undergone gastric bypass surgery for obesity -Patients receiving insulin sensitizer drugs such as metformin -Patients receiving treatment for dyslipidemia -Patients have the intention to reduce weight -Patients receiving treatment with GLP-1 receptor agonist

Design outcomes

Primary

MeasureTime frame
-To compare the effect between combined oral contraceptives (COCs) containing Estetrol (E4) 15 mg/ drospirenone (DRSP) 3 mg and ethinyl estradiol (EE) 30 mcg/DRSP 3 mg on glucose tolerance(2 hour 75 gm OGTT) in patients with polycystic ovarian syndrome (PCOS).Timepoint: At baseline 3 months after exposures 2 months after washout peroid 3 months after cross-over exposures—

Secondary

MeasureTime frame
-To compare the effects of different COCs on insulin levels in patients with PCOS. Timepoint: At baseline 3 months after exposures 2 months after washout peroid 3 months after cross-over exposures ;-To compare the effects of different COCs on menstrual patterns according to FIGO 2018(30) in patients with PCOS. Timepoint: At baseline and every months until 8 months—

Countries

Thailand

Contacts

Public ContactSatit Klangsin

Prince of Songkhla University

toeibunyapipat@gmail.com66858842988

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026