Effects of Melatonin in PCOS Women
- Registration Number
- NCT02663570
- Lead Sponsor
- Catholic University of the Sacred Heart
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description open Melatonin therapy with melatonin 2 mg daily for six months
- Primary Outcome Measures
Name Time Method Number of cycles in six months of therapy 6 months
- Secondary Outcome Measures
Name Time Method insulin levels 6 months tryglycerides 6 months hirsutism score 6 months Ferriman Gallwey score
LDL cholesterol 6 months androstenedione levels 6 months AMH levels 6 months testosterone levels 6 months free androgen index 6 months total cholesterol 6 months HDL cholesterol 6 months
Trial Locations
- Locations (1)
Catholic university of Sacred Heart
🇮🇹Rome, Italy