Polycystic ovary syndrome Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome
Conditions
Interventions
Two treatment subgroups:
Ethinylestradiol (20 ug) + levonorgestrel (100 mg), once daily at dinner time
Spironolactone (50 mg/d) + pioglitazone (7.5 mg/d) + metformin (8
Sponsors
Hospital Sant Joan de Deu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: As of 21/07/2016: 1. Clinical androgen excess (hirsutism) and/or biochemical hyperandrogenismwith or without biochemical androgen excess 2. Chronological age between 14.0-17.9 years at study start 3. Gynecological age (= time post-menarche) >2.0 years at study start 4. Absence of sexual activity (intercourse) Initial: 1.Clinical and biochemical hyperandrogenism 2. Hyperinsulinemia (fasting and/or after an oGTT) 3. Age >14 and >18 year 4. Menarche at least 2 years before 5. BMI 10th percentile
Exclusion criteria
Exclusion criteria: As of 21/07/2016: 1. Evidence for adrenal hyperplasia, Cushing syndrome, hypothyroidism 2. Evidence for lLiver or kidney dysfunction, diabetes, glucose intolerance 3. Treatment with oral contraceptives, antiandrogens, or insulin sensitizers in past 6 months Initial: 1. Pregnancy or pregnancy risk 2. Late onset congenital adrenal hyperplasia, Cushing's syndrome, uncompensated hypothyroidism 3. Liver or renal dysfunction, diabetes, glucose intolerance 4. Treatment with oral contraceptives, antiandrogens, or insulin sensitizers over the previous 6 months 5. Severe bacterial infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As of 21/07/2016: 1. Post-treatment ovulation rate: (judged by a combination of menstrual history and weekly salivary progesterone concentrations for 12 consecutive weeks, in the second and the fourth quarters of the first post-treatment year (months 15-18 and 21-24 of the study). As of 15/03/2016: 1. Ovulation rate: (weekly salivary progesterone for 12 consecutive weeks, ELISA): post-treatment; second and fourth quarters of the post-treatment year (months 15-18 and 21-24) Initial 1. Fasting insulin 2. Visceral fat 3. Hepatic fat 4. Carotid intima-media thickness | — |
Secondary
| Measure | Time frame |
|---|---|
| As of 15/03/2016: 1. Fasting insulinemia (immunochemiluminescence): at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment 2. Visceral fat (MRI): at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment 3. Hepatic fat (MRI): at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment 4. Carotid intima-media thickness (ultrasound): at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment 5. Hirsutism (Ferriman & Gallwey score): at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment 6. Testosterone and androstenedione (LC-MS/MS): at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment (changed from 6. Androgens (immunochemiluminescence): at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment on 21/07/2016)) 7. Lipids (absorption spectrometry): at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment 8. C-reactive protein (Architect c8000) : at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment 9. HMW adiponectin (ELISA): at baseline, 6 months and 12 months on treatment and 6 and 12 months off treatment Added 27/02/2019: 10. Serum miRNAs assessed by RNA-seq at baseline, and at 12 months and 24 months of follow-up Initial: 1. Ferriman & Gallwey score 2. Androgens 3. Lipids 4. C-reactive protein 5. High molecular weight 6. Adiponectin 7. Insulin resistance index in adipocytes 8. Ovulation 9. Breast density (DXA) | — |
Countries
Spain
Outcome results
None listed