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

Margan Biotech

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Dietary Supplement: Metionac; Drug: Oral contraceptive

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05340634

SOP-DIET

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Oral Contraceptive

Active Comparator group

Description:

Drospirenone 4 mg once a day for 6 months

Treatment:

Drug: Oral contraceptive

Oral Contraceptive + Food supplement Metionac

Experimental group

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

Treatment:

Dietary Supplement: Metionac

Drug: Oral contraceptive

Food supplement MetioNac

Other group

Description:

Metionac twice daily (200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg alpha lipoid acid and 0,65 Vitamin B6) for 6 months

Treatment:

Dietary Supplement: Metionac