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

Margan Biotech90 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

MetionacDIETARY_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 contraceptiveDRUG

Drospirenone 4 mg once a day

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Quironsalud San José

Madrid, Spain

Outcomes

Primary Outcomes

Change from Baseline in the Mean BMI at 6 Months

Evolution of Body Mass Index in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean Insuline level at 6 Months

Evolution of Insuline level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean Glucose level at 6 Months

Evolution of Glucose level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean Triglycerides at 6 Months

Evolution of Triglycerides level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean HDL at 6 Months

Evolution of high-density lipoprotein (HDL) cholesterol level in patients with PCOS after 6 months therapy.

Time frame: 6 months

Change from Baseline in the Mean LDL at 6 Months

Evolution of low-density lipoprotein (LDL) level in patients with PCOS after 6 months therapy

Time frame: 6 monhts

Change from Baseline in the Mean AST at 6 months

Evolution of aspartate aminotransferase (AST) level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean ALT at 6 months

Evolution of alanine aminotransferase (ALT) level in patients with PCOS after 6 months therapy

Data from ClinicalTrials.gov

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Secondary Outcomes

Change from Baseline in the Mean 17 beta estradiol at 6 months Translate from: English volume_up 20 / 5,000 Translation results Change from baseline in the Mean 17 beta estradiol at 6 Months

Evolution of 17 beta estradiol level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean 17 hydroxy progesterone at 6 months Translate from: English volume_up 20 / 5,000 Translation results Change from baseline in the Mean 17 beta estradiol at 6 Months

Evolution of 17 hydroxy progesterone level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean LH at 6 months Translate from: English volume_up 20 / 5,000 Translation results Change from baseline in the Mean 17 beta estradiol at 6 Months

Evolution of luteinizing hormone (LH) level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean FSH at 6 months Translate from: English volume_up 20 / 5,000 Translation results Change from baseline in the Mean 17 beta estradiol at 6 Months

Evolution of follicle-stimulating hormone (FSH) level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean Testosterone at 6 months

Evolution of testosterone level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean Androstenedione at 6 months

Evolution of androstenedione level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean DHEA at 6 months

Evolution of Dehydroepiandrosterone (DHEA) level in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean TSH at 6 months

Evolution of thyroid stimulating hormone (TSH) level in patients with PCOS after 6 months therapy.

Time frame: 6 months

Change from Baseline in the Mean Homocysteine at 6 months

Evolution of homocysteine (HC) level in patients with PCOS after 6 months therapy.

Time frame: 6 months

Change from Baseline in the Mean HOMA-IR at 6 months

Evolution of HOMA insulin resistance level in patients with PCOS after 6 months therapy.

Time frame: 6 months

Change from Baseline in the Mean Hb A1c at 6 months

Evolution of hemoglobin A1c in patients with PCOS after 6 months therapy.

Time frame: 6 months

Change from Baseline in the Mean SHBG at 6 months

Evolution of sex hormone binding globulin in patients with PCOS after 6 months therapy.

Time frame: 6 months

Change from Baseline in the Mean Hirsutism score at 6 months

Evolution of hirsutism score measured by Ferriman - Gallwey scale in patients with PCOS after 6 months therapy. The Ferriman-Gallwey scale for hirsutism. A score of 1 to 4 is given for nine areas of the body. A total score less than 8 is considered normal, a score of 8 to 15 indicates mild hirsutism, and a score greater than 15 indicates moderate or severe hirsutism. A score of 0 indicates absence of terminal hair.

Time frame: 6 months

Change from Baseline in the Mean Acne self-assessment score at 6 months

Evolution of acne self assessed from 1 to 10 (1 minimum severity, 10 maximum severity) in acne severity level in 3 areas: face, neck, back in patients with PCOS after 6 months therapy.

Time frame: 6 months

Change from Baseline in the Mean Alopecia score at 6 months

Evolution of alopecia using Ludwig scale in patients with PCOS after 6 months therapy. The Ludwig hair loss scale illustrates progressive hair loss patterns in women. It ranges from I to III. Stage I begins with thinning on the top of the head. In stage II the scalp starts to show. All of the hair at the crown of the head may be lost when the hair loss progresses to stage III.Stage I begins with thinning on the top of the head. In stage II the scalp starts to show. All of the hair at the crown of the head may be lost when the hair loss progresses to stage III.

Time frame: 6 months

Change from Baseline in the Proportion of patients with irregular menstrual cycle at 6 months

Regularization of irregular menstrual cycle in patients with PCOS after 6 months therapy

Time frame: 6 months

Change from Baseline in the Mean Migraine score at 6 months

Evolution of migraine score using Migraine Disability Assessment test (MIDAS) in patients with PCOS after 6 months. The MIDAS score is derived as the sum of missed days due to a headache over a 3-month period in the three domains: school work or work for pay; household work or chores; and family, social, and leisure activities. The four-point grading system for the MIDAS questionnaire is as follows: • Grade 1 (scores ranging from 0 to 5): little or no disability Grade 2 (scores ranging from 6 to 10): mild disability Grade 3 (scores ranging from 11 to 20): moderate disability Grade 4 (21 or greater): severe disability.

Time frame: 6 months

Change from Baseline in the Mean QoL score at 6 months

Evolution of quality of life score using Health-Related Quality of Life Questionnaire for women with Polycystic Ovary Syndrome (adapted from PCOSQ qustionnaire) in patients with PCOS after 6 months therapy. The PCOS HRQL questionnaire represents a new measure for women with PCOS and includes five domains: emotional, body hair, infertility, weight, and menstrual problems. A shorten version with 19 questions was used. It ranges from 0 (no impact on quality of life to 114 maximum negative impact in the patient´s quality of life.

Time frame: 6 months