Polycystic Ovary Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meeting the diagnostic criteria for PCOS established by the American and European Reproductive Societies in Rotterdam, the Netherlands in 2003. Participants must satisfy at least two of the following three criteria while excluding other causes of ovulation disorders and hyperandrogenism: (1) chronic oligo- or anovulation (infrequent or absent ovulation); (2) clinical (hirsutism and acne) or biochemical hyperandrogenism (excessive levels of androgens); (3) polycystic changes of ovary seen by intravitreal ultrasonography (>=12 follicles measuring 2-9 mm in size or unilateral ovarian volume >=10 ml). 2. Non-obese: Body Mass Index (BMI) < 25 kg/m^2, according to the 2003 Chinese Guidelines for the Prevention and Control of Overweight and Obesity in Adults; 3. No use of the following pharmacological interventions in the 3 months prior to enrolment, including metformin, acarbose, pioglitazone hydrochloride, oral contraceptive pills, and spironolactone; 4. Age and sex: Females aged 18 - 35 years (inclusive).
Exclusion criteria
Exclusion criteria: 1. Suffering from severe hepatic or renal dysfunction with alanine aminotransferase (ALT) > 2.5 times the upper limit of normal, or creatinine (Cr) > 132 umol/l, or estimated glomerular filtration rate (eGFR) = class III; 3. With myasthenia gravis, dermatomyositis, Duchenne muscular dystrophy, and other neurological, rheumatic, or hereditary myopathies; 4. Being breastfeeding or pregnant. 5. Participated in a clinical trial of another drug within 3 months. 6. History of clearly diagnosed mental illness. 7. Presence of an eating disorder or anorexia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total testosterone;Biceps Muscle Strength;Quadriceps Muscle Strength;Grip Strength;Counter-Movement Jump Height;Plank Support Time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Luteinizing hormone;Follicle-stimulating hormone;Estradiol;Fasting plasma glucose;Fasting serum insulin;Homeostatic model assessment for insulin resistance;Glycated hemoglobin A1c;Total cholesterol;Triglyceride;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;Skeletal Muscle;Body Mass Index;Body Fat Percentage;Menstrual Distress Questionnaire Score; | — |
Countries
China
Contacts
Shanghai Jiaotong University School of Medicine, Renji Hospital