Status:
COMPLETED
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
Lead Sponsor:
AGUNCO Obstetrics and Gynecology Centre
Conditions:
PCOS
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01511822
Last Update
January 19 2012
Active Locations (1)
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1
Istituto di Patologia Ostetrica e Ginecologica
Catania, Italy