Metformin and Oral Contraceptives in PCOS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in fasting insulin and area under the curve for insulin (2 hours)
研究概览
简要总结
Background: PCOS is a common condition with a prevalence of 5-8 % in premenopausal women. More than 50% of PCOS patients are insulin resistant and have a diabetes risk 5-8 times higher than age- and weight-matched controls. Studies using insulin sensitizers in PCOS found increased insulin sensitivity and decreased insulin levels to be followed by decreased androgen levels and improved ovulatory function. No studies however, evaluated the long term effects of insulin sensitizing treatment.
Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS, however no long-term studies evaluated the effects of combined treatment with metformin and oral contraceptives in PCOS.
Design: Randomized open study in 3*30 PCOS patients. Patients are randomised to 24 months of treatment with 1: metformin, 2: metformin and oral contraceptives or 3: oral contraceptives.
Primary outcome measures: fasting insulin, AUC insulin. Secundary endpoints: BMI, WHR, LH, FSH, total and free-testosterone, c-peptid, urinary cortisol, AUC for insulin, glucose and c-peptid during OGTT.
Inclusioncriteria:
- Irregular menses or anovulaty cycles
- High free testosterone > 0,035 nmol/l or hirsutism
- PCO in vaginal US Criteria 1 and 2 OR 2 and 3.
Design:
详细描述
90 patients are included and randomized to 12 months of treatment with metformin (1000+1000 mg/d) or OCP (150 mg desogestrel 30 microgram ethinylestradiol) or combined treatment (metformin+OCP).
Patients attend a biochemical and physical examination at study inclusion and at 12 months. Patients attend for registration of side effects and compliance after 6 months of study duration. Safety tests are performed at all three visits and include weight, blood pressure, HbA1c, liver enzymes, electrolytes, and white blood cell count. Pregnancy tests are performed by the participants each month. Patients are given general advice on lifestyle intervention. Patients are excluded if they initiated medical treatment with possible hormonal and metabolic effects during the intervention period. Lifestyle intervention is allowed. Laser treatment is offered to patients with moderate or severe facial hirsutism and patients are allowed to shave/wax. The patients accept not applying cosmetic treatment 3-4 days before attending for evaluation at the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Irregular menses or anovulaty cycles
- •High free testosterone > 0.035 nmol/l or hirsutism
- •PCO in vaginal US Criteria 1 and 2 OR 2 and 3
排除标准
- •Age > 18 years
- •Postmenopausal
- •Diagnosis diabetes mellitus
- •Use of medicine known to affect hormones measured in the project
- •Pregnancy or planned pregnancy during study period
- •Non-Caucasian
- •Previous tromboembolic disease
- •Heavy smoker > 35 years and BMI > 35 kg/m2
研究组 & 干预措施
1
metformin
干预措施: Metformin (Drug)
2
desorelle
干预措施: Desorelle (Drug)
3
desorelle + metformin
干预措施: Metformin (Drug)
3
desorelle + metformin
干预措施: Desorelle (Drug)
结局指标
主要结局
Changes in fasting insulin and area under the curve for insulin (2 hours)
时间窗: 12 months
次要结局
- Changes in BMD, BMI, WHR, LH, FSH, total and free testosterone, fasting blood glucose, fasting C-peptide, urine-cortisol secretion, body composition, number of hypoglycaemic cases, AUC for insulin, glucose and C-peptide during OGTT (2 and 5 ho(12 months)
- Changes in cortisol metabolism(12 months)
- Changes in the prevalence of reactive hypoglycemia and areal under the curve for glucose (5 hours)(12 months)
研究者
Marianne Andersen
Professor
Odense University Hospital