A Phase 4 interventional study of Drospirenone Ethinyl estradiol and Drospirenone Ethinyl estradiol Myo-inositol in PCOS and Polycystic Ovary Syndrome, sponsored by AGUNCO Obstetrics and Gynecology Centre. Completed at 1 site in Italy. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2012-01-19.
Sponsored by AGUNCO Obstetrics and Gynecology Centre · Phase 4 and Interventional
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.
Browse Polycystic Ovary Syndrome studies →AGUNCO Obstetrics and Gynecology Centre is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Drospirenone Ethinyl estradiol
Drug: Drospirenone Ethinyl estradiol Myo-inositol
Drug: placebo
Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/month for 6 months)
Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/months for 6 months) + Myo-inositol 6g /die for 6 months
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
Number of patients with adverse effects
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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AGUNCO Obstetrics and Gynecology Centre