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Evaluation of Metionac for the Modulation of Metabolic and Endocrine Parameters in Patients With PCOS.

Polycystic Ovary Syndrome Clinical Trial

Official title:
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.

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05340634
Study type Interventional
Source Margan Biotech
Contact
Status Completed
Phase Phase 4
Start date April 20, 2020
Completion date February 2, 2022
View Details
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