Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Micronutrients

All Drugs and Chemicals

Natriuretic Agents

Reproductive Control Agents

Vitamins

Vitamin B 6

Pyridoxal

Pyridoxine

Drospirenone

Vitamin B Complex

Antioxidants

Contraceptive Agents

Contraceptives, Oral

Contraceptive Agents, Female

Vitamin B6

Drospirenone 4 mg once a day for 6 months

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

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

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

Metionac

Oral contraceptive

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).

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.

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

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

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

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

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

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

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

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

Evolution of gamma glutamyltransferase (GGT) level in patients with PCOS after 6 months therapy

Evolution of total and free bilirubin level in patients with PCOS after 6 months therapy

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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.

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

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.

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.

Spots Global Cancer Trial Database for metionac

Every month we try and update this database with for metionac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for metionac

Every month we try and update this database with for metionac cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for metionac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.