Status:
COMPLETED
Evaluation of Metionac for the Modulation of Metabolic and Endocrine Parameters in Patients With PCOS.
Lead Sponsor:
Margan Biotech
Collaborating Sponsors:
Grupo CINUSA (Centros de Investigación en Nutrición y Salud S.L.)
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 PCO...
Detailed 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 or...
Eligibility Criteria
Inclusion
- 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
- Diabetic women
- Adrenal enzyme deficiency and/or other endocrine disease
- Pregnant or lactating women.
- Women under treatment with SNRIs (serotonin reuptake inhibitors)
- Other serious illness
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05340634
Start Date
April 20 2020
End Date
February 2 2022
Last Update
April 28 2022
Active Locations (1)
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1
Hospital Quironsalud San José
Madrid, Spain