Polycystic Ovary Syndrome
Conditions
Brief summary
The aim of our study is to investigate the effects of a treatment with melatonin on clinical, endocrine and metabolic features in women affected by PCOS. The study group included 40 patients treatend with 2 mg of melatonin daily for six months. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian volume and antral follicular count, an oral glucose tollerance test and hormonal assays are evaluated before and after therapy.
Interventions
DRUGMelatonin
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 diseases * diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test) * hypertension * significant liver or renal impairment * other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal) * neoplasms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cycles in six months of therapy | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL cholesterol | 6 months | — |
| hirsutism score | 6 months | Ferriman Gallwey score |
| testosterone levels | 6 months | — |
| insulin levels | 6 months | — |
| HDL cholesterol | 6 months | — |
| tryglycerides | 6 months | — |
| androstenedione levels | 6 months | — |
| free androgen index | 6 months | — |
| AMH levels | 6 months | — |
| total cholesterol | 6 months | — |
Countries
Italy
Outcome results
None listed