Positive Clinical and Hormonal Effects of Ethinylestradiol Combined With Drospirenone (EE/DRSP) in Women With Polycystic Ovary Syndrome (PCOS): Impact of Body Weight and Relevance to Hyperandrogenism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Biochemical Assessment of Hyperandrogenism
研究概览
简要总结
The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS effectively reduces circulating androgens. Although OCs are the most common and one of the oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of PCOS women with different body mass index (BMI) are limited. This study is being done to compare the hormone and metabolic changes after treatment with low-dose oral birth control regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS with different body weights.
详细描述
Clinically, polycystic ovary syndrome (PCOS) is a heterogeneous disorder of functional androgen excess and the features of PCOS can run through a spectrum of severity. The optimal modality for long-term treatment of PCOS should positively influence androgen synthesis, sex hormone binding globulin (SHBG) production, insulin sensitivity, the lipid profile, and clinical symptoms including hirsutism and irregular menstrual cycles. Combined oral contraceptives have been a key component of the chronic treatment of women with PCOS; improving androgen excess and regulating menstrual cycles. The effect of OCs on ovarian folliculogenesis significantly decreases androgen production. This mechanism was confirmed in both healthy women and women with PCOS. In obese patients with PCOS, it is likely that the suppression of androgen production is not as significant. It is thus possible to hypothesize that the effects of OCs in PCOS could be dependent on body weight and what is needed is a head-to-head comparison. The aim of this study is to compare the effect of 6 months of a low-dose oral contraceptive regimen of 24/4 DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg on androgen profiles, cardiometabolic measures, B-vitamin status, and menstrual cycle regulation in three groups, normal (BMI 18-24.9 kg/ m2) overweight (BMI 25-29.9 kg/ m2) and obese (BMI 30-35 kg/ m2) women with PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- ••Adult female-16 years to 35 years of age who have been diagnosed with PCOS desiring contraception
- •Actual BMI >18 to <35kg/ m2
- •Written consent for participation in the study
- •Patient completed lactation
排除标准
- •Metabolic abnormalities requiring pharmacological intervention (except controlled thyroid disease)
- •Uncontrolled hypertension
- •Cancer or history of hormone-dependent cancer
- •History of cholestasis
- •Presence of contradictions for OC administration
- •Personal history of cardiovascular events.
- •Use of drugs known to exacerbate glucose tolerance.
- •No prescription or over-the-counter weight-loss drugs
- •Use of medications that affect blood pressure or lipid profile
- •Smoking in past 6 months
- •Known thrombogenic mutations (e.g. Factor V Leiden)
- •Current or history of deep venous thrombosis/pulmonary embolism
- •Major surgery with prolonged immobilization
- •Injectable hormonal contraceptive use within 6 months
- •Use of hormonal (e.g., oral contraceptive [OC] pill) or insulin-sensitizing medication unless willing to cease medications for 3 months before study measurements
研究组 & 干预措施
3 mg DRSP/20 μg EE--normal weight
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
Normal weight -BMI 18-24.9 kg/ m2
干预措施: 3 mg DRSP/20 μg EE (Drug)
3 mg DRSP/20 μg EE- Overweight
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 25-29.9 kg/ m2
干预措施: 3 mg DRSP/20 μg EE (Drug)
3 mg DRSP/20 μg EE- Grade 1 obese
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 30-34.9 kg/ m2
干预措施: 3 mg DRSP/20 μg EE (Drug)
结局指标
主要结局
Biochemical Assessment of Hyperandrogenism
时间窗: 24 weeks
The primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units. FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100
次要结局
- Cardiometabolic Measures(24 weeks)
- Post Therapy BMI.(24 weeks)
- Adrenal Androgen DHEAS(24 weeks)
- Oral Disposition Index(24 weeks)
- Biochemical Indicator of B-vitamin Status(24 weeks)
- Menstrual Cycle Regularity(24 weeks)
研究者
Karen Elkind-Hirsch
Scientific Director of Research
Woman's