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

Phase 4

Completed

• Conditions: PCOS; Polycystic Ovary Syndrome
• Interventions: Drug: Drospirenone Ethinyl estradiol; Drug: placebo; Drug: Drospirenone Ethinyl estradiol Myo-inositol

• Registration Number: NCT01511822
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-18
• Last Update Submitted: 2012-01-18
• Study First Posted: 2012-01-19
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drospirenone + Ethinyl estradiol	Drospirenone Ethinyl estradiol	-
Placebo	placebo	-
Drospirenone + Ethinyl estradiol + Myo-inositol	Drospirenone Ethinyl estradiol Myo-inositol	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse effects

Trial Locations

Locations (1)

Istituto di Patologia Ostetrica e Ginecologica; 🇮🇹 Catania, Italy