Clinical trial · Interventional
Evaluation of Metionac for the Modulation of Metabolic and Endocrine Parameters in Patients With PCOS.
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.
NCT05340634CI-TRIAL-00058131completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metionac | Dietary Supplement | — | UNRESOLVED |
| Oral contraceptive | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Oral Contraceptive
- description
- Drospirenone 4 mg once a day for 6 months
- interventionNames
- Drug: Oral contraceptive
- type
- EXPERIMENTAL
- label
- Oral Contraceptive + Food supplement Metionac
- description
- Drospirenone 4 mg once a day and Metionac twice daily (200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg alpha lipoid acid and 0,65 Vitamin B6) for 6 months
- interventionNames
- Dietary Supplement: Metionac
- Drug: Oral contraceptive
- type
- OTHER
- label
- Food supplement MetioNac
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 illnessReferences
Publications (0)
Data not yet available
No reference posted for this study.