Evaluation of the Efficacy of the Combination of Antioxidants Metionac for the Modulation of Metabolic and Endocrine Parameters in Patients With Polycystic Ovary Syndrome: A Prospective Randomized Study.
Evaluation of the Efficacy of the Combination of Antioxidants Metionac for the Modulation of Metabolic and Endocrine Parameters in Patients With Polycystic Ovary Syndrome: A Prospective Randomized Study.
Evaluate the efficacy of the combination of antioxidants ALA, NAC, Vit. B6 and SAMe as a dietary supplement, in the improvement of metabolic and endocrine parameters and clinical manifestations of PCOS.
The investigators will explain the study to all patients who meet the inclusion and exclusion criteria during the study period. After signing the informed consent patients will be randomized 1:1 to oral contraceptive 4 mg drospirenone once daily or oral contraceptive 4 mg drospirenone + combination of 200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg Alpha lipoid acid and 0,65 mg vitamin B6 (Metionac) twice daily. Patients for whom oral contraceptive is not indicated will be enrolled in third study group of Metionac twice daily. 2 study visits will be carried out, Baseline (Visit 0) and after 6 months therapy (Visit 1).
Inclusion Criteria:
Women newly diagnosed with PCOS with at least 2 of the following symptoms:
Oligo/Anovulation < 21 or > 35 days > 90 days (any cycle) < 8 periods / year
Hyperandrogenism (clinical symptoms or laboratory results)
Polycystic ovary morphology (NHMRC guideline): In any ovary:
20 follicles* and/or ovarian volume greater than or equal to 10ml and no corpus luteum, cysts or dominant follicles
*number of follicles per ovary measuring 2-9 mm
> 18 years old
Overweight defined as BMI>25
Normal prolactin levels
Women with altered coagulation factors or a personal history of thromboembolism for whom OAC is contraindicated (they will be included in the control group without randomization)
Written inform consent
Exclusion Criteria: