The Comparison of Contraceptive pills containing Estetrol/Drospirenone versus Ethinyl Estradiol/Drospirenone in effects on Blood sugar in PCOS wome
- Conditions
- Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
- Registration Number
- CTRI/2023/12/060847
- Lead Sponsor
- Faculty of Medicine Research Scholarship, Prince of Songkhla university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Applicable
- Sex
- Not specified
- Target Recruitment
- 0
A diagnosis of PCOS according to the modified 2003 Rotterdam diagnostic 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -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 <br/ ><br>3 months after exposures <br/ ><br>2 months after washout peroid <br/ ><br>3 months after cross-over exposures
- Secondary Outcome Measures
Name Time Method -To compare the effects of different COCs on insulin levels in patients with PCOS. <br/ ><br> <br/ ><br>Timepoint: At baseline <br/ ><br>3 months after exposures <br/ ><br>2 months after washout peroid <br/ ><br>3 months after cross-over exposures <br/ ><br>;-To compare the effects of different COCs on menstrual patterns according to FIGO 2018(30) in patients with PCOS. <br/ ><br>Timepoint: At baseline and every months until 8 months