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
试验速览
- 阶段
- 3 期
- 状态
- Not Applicable
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- -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).
研究概览
简要总结
Polycystic ovarian syndrome (PCOS), the main endocrine disorder, has an estimated prevalence of 6–10 percent among reproductive-aged women. It is associated with irregular menstruation, infertility, hirsutism, and metabolic syndrome, especially elevated insulin resistance (IR). IR resulted in impaired glucose tolerance (IGT) among 30–40% of PCOS. Treatment of PCOS involves lifestyle modification and medication, especially combined oral contraceptives (COCs), particularly COCs containing drospirenone (DRSP), which inhibits mineralocorticoid effects and demonstrates anti-androgenic activity.
COCs containing EE and DRSP did not affect fasting blood sugar (FBS), fasting insulin, HOMA-IR, oral glucose tolerance test (OGTT), or insulin under the curve (IR-AUC) at 3 months compared to baseline.
In menopausal women, E4 did not result in any significant change in fasting glucose levels. However, it did exhibit positive effects on insulin resistance, hemoglobin A1c, and glucose tolerance.
A novel form of COCs contains 15 mg of E4 and 3 mg of DRSP, which does not affect FBS, or insulin levels in non-PCOS women. Based on treatment in PCOS, there is a lack of studies on the impact of COCs containing E4/DRSP on carbohydrate metabolism. Hence, the objective of this study is to compare COCs containing E4/DRSP versus EE/DRSP on glucose tolerance in PCOS women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •A diagnosis of PCOS according to the modified 2003 Rotterdam diagnostic criteria.
排除标准
- •Patients with contraindications to the use of COCs, according to MEC categories 3 and
- •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.
结局指标
主要结局
-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).
时间窗: At baseline | 3 months after exposures | 2 months after washout peroid | 3 months after cross-over exposures
次要结局
- -To compare the effects of different COCs on insulin levels in patients with PCOS.
- -To compare the effects of different COCs on menstrual patterns according to FIGO 2018(30) in patients with PCOS.