NCT04257500已完成4 期
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS
Andrea Roe, MD, MPH1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Incidence of Metabolic Syndrome
研究概览
简要总结
A prospective study to determine the metabolic effects of the contraceptive vaginal ring among overweight and obese women with polycystic ovary syndrome (PCOS). We will recruit a total of 40 participants and study use of the vaginal ring over a 4-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PCOS according to Rotterdam criteria, with at least 2 of 3 of the following criteria: oligomenorrhea (≤8 periods per year), clinical or biochemical hyperandrogenism, and polycystic ovaries on ultrasound
- •Body mass index ≥25 and ≤45 kg/m2
- •In good general health according to the investigators' discretion
- •Willing to avoid pregnancy for the duration of the study
排除标准
- •Current pregnancy or desire for pregnancy during course of study
- •Current breastfeeding
- •Second-trimester pregnancy within four weeks prior to initiation of NuvaRing or third-trimester pregnancy within 6 months prior to initiation of NuvaRing
- •Use of hormonal contraception within four weeks prior to initiation of NuvaRing
- •Diagnosis of metabolic syndrome. Metabolic syndrome will be defined according to the updated Adult Treatment Panel III as 3 or more of the following criteria: blood pressure ≥130/85 mm Hg, waist circumference >35 inches, fasting glucose ≥110 mg/dL, TG ≥150 mg/dL, HDL-C <50 mg/dL.
- •Contraindications to NuvaRing use:
- •Age ≥ 35 plus tobacco use
- •Current or past deep vein thrombosis or pulmonary embolism
- •Cerebrovascular disease
- •Coronary artery disease
- •Thrombogenic valvular or rhythm diseases of the heart (such as subacute bacterial endocarditis with valvular disease or atrial fibrillation)
- •Inherited or acquired coagulopathy
- •Headaches with focal neurological symptoms or migraine headaches with aura
- •Age ≥ 35 plus any migraine headaches
- •Liver tumors, benign or malignant
- •Undiagnosed abnormal uterine bleeding
- •Current or past breast cancer or other estrogen- or progestin-sensitive cancer
- •Hypersensitivity to any of the components of NuvaRing
- •Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir
- •Medical comorbidities:
- •21-hydroxylase deficiency, congenital adrenal hyperplasia
- •Untreated thyroid disease
- •Untreated hyperprolactinemia
- •Type 1 or 2 diabetes mellitus
- •Uncontrolled liver disease
- •Uncontrolled renal disease
- •Current alcohol abuse
- •Hypertension ≥ 140 mm Hg average systolic or ≥ 90 mm Hg average diastolic in women using anti-hypertensive medication
- •Hypertension ≥ 150 mm Hg average systolic or ≥ 100 mm Hg average diastolic in women not using anti-hypertensive medication
- •History of or current gynecologic cancer
- •Triglycerides >=250 mg/dL
- •Current use of lipid-lowering or weight loss agents
- •Participation in any study of an investigational drug or device or biologic agent within 30 days
- •Suspected adrenal or ovarian tumor secreting androgens
- •Suspected Cushing's syndrome
- •Bariatric surgery within 12 months
- •Other medical concerns that in the judgment of the investigator may compromise safety of the participant or confound the reliability of compliance and information acquired in this study
研究组 & 干预措施
Contraceptive Ring
Experimental
Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily.
干预措施: Etonogestrel/ethinyl estradiol vaginal ring (Drug)
结局指标
主要结局
Incidence of Metabolic Syndrome
时间窗: 4 months
Metabolic Syndrome defined according to the updated Adult Treatment Panel III as 3 or more of the following criteria: blood pressure ≥130/85 mm Hg, waist circumference \>35 inches, fasting glucose ≥110 mg/dL, TG ≥150 mg/dL, HDL-C \<50 mg/dL.
次要结局
- Change in high-density lipoprotein (HDL) measure(4 months)
- Change in low-density lipoprotein (LDL) measure(4 months)
- Change in apolipoprotein A(4 months)
- Change in fasting 2 hour oral Glucose Tolerance Test result(4 months)
- Change in Ferriman-Gallwey Hirsutism score(4 months)
- Body Mass Index(4 months)
- Change in scoring on the Center for Epidemiologic Studies Depression Scale(4 months)
- Change in scoring on the State-Trait Anxiety Inventory(4 months)
- Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire(4 months)
- Change in cholesterol efflux capacity(4 months)
- Change in triglycerides measure(4 months)
- Change in apolipoprotein B(4 months)
- Change in advanced lipid testing measure(4 months)
- Change in fasting insulin level(4 months)
- Change in Testosterone(4 months)
研究者
Andrea Roe, MD, MPH
Assistant Professor of Obstetrics and Gynecology
University of Pennsylvania
研究点 (1)
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