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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2022-02-02

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Contraceptive

Drospirenone 4 mg once a day for 6 months

Group Type ACTIVE_COMPARATOR

Oral contraceptive

Intervention Type DRUG

Drospirenone 4 mg once a day

Oral Contraceptive + Food supplement Metionac

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

Group Type EXPERIMENTAL

Metionac

Intervention Type DIETARY_SUPPLEMENT

Metionac is a food suplement composed by 200 mg of SAMe, 100 mg of NAC, 75 mg of ALA and 0,65 mg of vitamin B6 per tablet for 6 months

Oral contraceptive

Intervention Type DRUG

Drospirenone 4 mg once a day

Food supplement MetioNac

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

Group Type OTHER

Metionac

Intervention Type DIETARY_SUPPLEMENT

Metionac is a food suplement composed by 200 mg of SAMe, 100 mg of NAC, 75 mg of ALA and 0,65 mg of vitamin B6 per tablet for 6 months

Interventions

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Metionac

Metionac is a food suplement composed by 200 mg of SAMe, 100 mg of NAC, 75 mg of ALA and 0,65 mg of vitamin B6 per tablet for 6 months

Intervention Type DIETARY_SUPPLEMENT

Oral contraceptive

Drospirenone 4 mg once a day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No