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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drospirenone + Ethinyl estradiol | Active Comparator |
| |
| Drospirenone + Ethinyl estradiol + Myo-inositol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drospirenone Ethinyl estradiol | Drug | Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/month for 6 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score acne (acne grading system by Cook et al) | ||
| Score hirsutism (Ferriman-Gallwey classification) | ||
| Measurement of sex hormones in serum | ||
| Oral glucose tolerance test (OGTT) | ||
| Measurement of blood glucose and insulin levels | ||
| BMI |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto di Patologia Ostetrica e Ginecologica | Catania | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22122627 | Background | D'Anna R, Di Benedetto V, Rizzo P, Raffone E, Interdonato ML, Corrado F, Di Benedetto A. Myo-inositol may prevent gestational diabetes in PCOS women. Gynecol Endocrinol. 2012 Jun;28(6):440-2. doi: 10.3109/09513590.2011.633665. Epub 2011 Nov 28. | |
| 21417594 | Background | Minozzi M, Costantino D, Guaraldi C, Unfer V. The effect of a combination therapy with myo-inositol and a combined oral contraceptive pill versus a combined oral contraceptive pill alone on metabolic, endocrine, and clinical parameters in polycystic ovary syndrome. Gynecol Endocrinol. 2011 Nov;27(11):920-4. doi: 10.3109/09513590.2011.564685. Epub 2011 Mar 21. |
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| Drospirenone Ethinyl estradiol Myo-inositol | Drug | Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/months for 6 months) + Myo-inositol 6g /die for 6 months |
|
| placebo | Drug |
|
| 18728832 | Background | Mathur R, Levin O, Azziz R. Use of ethinylestradiol/drospirenone combination in patients with the polycystic ovary syndrome. Ther Clin Risk Manag. 2008 Apr;4(2):487-92. doi: 10.2147/tcrm.s6864. |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| D017588 | Hyperandrogenism |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
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