Polycystic Ovary Syndrome Clinical Trial
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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N/A | |
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N/A | |
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Phase 4 | |
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N/A | |
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Phase 3 | |
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N/A | |
| Completed |
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||
| Completed |
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|
Phase 2 | |
| Completed |
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Phase 2/Phase 3 | |
| Completed |
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N/A | |
| Not yet recruiting |
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Phase 3 | |
| Completed |
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N/A | |
| Completed |
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Phase 4 | |
| Withdrawn |
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N/A |