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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedJanuary 19, 2012
January 1, 2012
January 11, 2012
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Secondary Outcomes (1)
Number of patients with adverse effects
Study Arms (3)
Drospirenone + Ethinyl estradiol
ACTIVE COMPARATORDrospirenone + Ethinyl estradiol + Myo-inositol
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto di Patologia Ostetrica e Ginecologica
Catania, Italy
Related Publications (3)
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.
PMID: 22122627BACKGROUNDMinozzi 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.
PMID: 21417594BACKGROUNDMathur 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.
PMID: 18728832BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2012
First Posted
January 19, 2012
Last Updated
January 19, 2012
Record last verified: 2012-01