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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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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Detailed Description

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Conditions

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PCOS Polycystic Ovary Syndrome

Study Groups

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Drospirenone + Ethinyl estradiol

Group Type ACTIVE_COMPARATOR

Drospirenone Ethinyl estradiol

Intervention Type DRUG

Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/month for 6 months)

Drospirenone + Ethinyl estradiol + Myo-inositol

Group Type EXPERIMENTAL

Drospirenone Ethinyl estradiol Myo-inositol

Intervention Type DRUG

Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/months for 6 months) + Myo-inositol 6g /die for 6 months

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Drospirenone Ethinyl estradiol

Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/month for 6 months)

Intervention Type DRUG

Drospirenone Ethinyl estradiol Myo-inositol

Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/months for 6 months) + Myo-inositol 6g /die for 6 months

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No