EVALUATION OF THE COMBINATION OF ANTIOXIDANTS METIONAC FOR THE MODULATION OF METABOLIC AND ENDOCRINE PARAMETERS IN PATIENTS WITH PCOS: A PROSPECTIVE RANDOMIZED STUDY

• Status: Completed
• Trial end date: 2022-02-02
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Margan Biotech
• Collaborator: Grupo CINUSA (Centros de Investigación en Nutrición y Salud S.L.)
• Treatments: Contraceptive Agents; Contraceptives, Oral

Criteria

Inclusion Criteria:

1. 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

2. > 18 years old

3. Overweight defined as BMI>25

4. Normal prolactin levels

5. 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)

6. Written inform consent

Exclusion Criteria:

1. Diabetic women

2. Adrenal enzyme deficiency and/or other endocrine disease

3. Pregnant or lactating women.

4. Women under treatment with SNRIs (serotonin reuptake inhibitors)

5. Other serious illness