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临床试验/NCT01511822
NCT01511822已完成4 期

Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance

AGUNCO Obstetrics and Gynecology Centre1 个研究点 分布在 1 个国家开始时间: 2012年1月19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
试验地点
1
主要终点
BMI

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and endocrine abnormalities and clinical symptoms.

The primary defect in PCOS consists of an abnormal androgen synthesis and secretion, particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers, explaining the frequent association of PCOS with these metabolic conditions. Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and adrenal androgen secretion and suppresses sex hormone-binding globulin synthesis from the liver. It results in an increase in free, biologically active androgens which are related to clinical signs such as hirsutism, acne, seborrhea, and alopecia.

Combined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely used in this group of patients providing clinical improvement in the areas of excessive hair growth, unpredictable menses, acne, and weight gain.

More recent studies outlined a deficiency in myo-inositol in women with PCOS and insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and it plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle trafficking, and chromatin remodeling. It is a precursor in the synthesis of phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers.

It has been reported that the administration of myo-inositol reduces serum insulin, decreases serum testosterone and enhances ovulation.

Due to the different beneficial actions, the aim of the present study is to evaluate the clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin resistance.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women fulfilled two out of three diagnostic criteria for PCOS, according to the 2003 Rotterdam Consensus conference
  • Women with PCOS, insulin resistance, acne, hirsutism and seborrhea

排除标准

  • Women with pre-existing secondary endocrine disorders
  • Women wishing to conceive during the next 12 months
  • Women with contradictions to oral contraceptive use
  • Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
  • Women who received treatment with oral contraceptives, or other drugs for the previous 6 months before entering the study.

研究组 & 干预措施

Drospirenone + Ethinyl estradiol

Active Comparator

干预措施: Drospirenone Ethinyl estradiol (Drug)

Drospirenone + Ethinyl estradiol + Myo-inositol

Experimental

干预措施: Drospirenone Ethinyl estradiol Myo-inositol (Drug)

Placebo

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

BMI

Oral glucose tolerance test (OGTT)

Score acne (acne grading system by Cook et al)

Score hirsutism (Ferriman-Gallwey classification)

Measurement of sex hormones in serum

Measurement of blood glucose and insulin levels

次要结局

  • Number of patients with adverse effects

研究者

发起方
AGUNCO Obstetrics and Gynecology Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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