PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives
Launched by FEDERICO II UNIVERSITY · Jul 28, 2009
Trial Information
Current as of May 08, 2025
Completed
Keywords
ClinConnect Summary
Subjects:
Twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were consecutively admitted to the Endocrinology Unit of the Department of Molecular and Clinical Endocrinology and Oncology of the Federico II University of Naples, and were enrolled in this clinical study. The diagnosis of PCOS was made according to the diagnostic criteria for PCOS At study entry the patients were randomized in two groups of treatment, according to insulin sensitivity. OCP group, 10 patients (BMI 29.7± 1.5 kg/m2) received 30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month. MET group, 10 patie...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • female
- • premenopausal
- • obesity
- • PCOS.
- Exclusion Criteria:
- • pregnancy
- • type 2 diabetes or impaired glucose tolerance
- • hypothyroidism
- • hyperprolactinaemia
- • Cushing's syndrome
- • nonclassical congenital adrenal hyperplasia
- • previous (within the last 6 months) use of oral contraceptives
- • glucocorticoids
- • antiandrogens
- • ovulation induction agents
- • antidiabetic and antiobesity drugs, or other hormonal drugs.
- • None of the subjects was affected by any neoplastic, metabolic, hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, and malabsorptive disorders),acute and chronic inflammations based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.
About Federico Ii University
Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Annamaria Colao, MD PhD
Principal Investigator
Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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