Hyperandrogenism, Menstrual Pattern, Metabolic Features, Polycystic Ovary Syndrome
Conditions
Brief summary
The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose tolerance test, lipidic profile at baseline and after six months of treatment.
Interventions
DRUGmyo-inositol,alpha-lipoic acid and folic acid
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* women with PCOS in accordance with Rotterdam criteria
Exclusion criteria
* pregnancy * past history of cardiovascular disease, * diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), * hypertension, * significant liver or renal impairment, * other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs), * neoplasms, * unstable mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cycles in six months of therapy | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperandrogenism | 6 months | Testosterone, Androstenedione, free androgen index |
| Insulin response to oral glucose tolerance test | 6 months | — |
| Lipidic profile | 6 months | Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride |
| Hirsutism | 6 months | Ferriman Gallwey score |
Outcome results
None listed