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.

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Oral contraceptive; Dietary supplement: Metionac

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Quironsalud San José

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Oral Contraceptive; Drospirenone 4 mg once a day for 6 months	Drug: Oral contraceptive; Drospirenone 4 mg once a day
EXPERIMENTAL: 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	Drug: Oral contraceptive; Drospirenone 4 mg once a day; Dietary supplement: 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
OTHER: 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	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Mean BMI at 6 Months	Evolution of Body Mass Index in patients with PCOS after 6 months therapy	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	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	6 months
Change from Baseline in the Mean Triglycerides at 6 Months	Evolution of Triglycerides level in patients with PCOS after 6 months therapy	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.	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	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	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	6 months
Change from Baseline in the Mean GGT at 6 months	Evolution of gamma glutamyltransferase (GGT) level in patients with PCOS after 6 months therapy	6 months
Change from Baseline in the Mean Bilirubin at 6 Months	Evolution of total and free bilirubin level in patients with PCOS after 6 months therapy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	6 months
Change from Baseline in the Mean Testosterone at 6 months	Evolution of testosterone level in patients with PCOS after 6 months therapy	6 months
Change from Baseline in the Mean Androstenedione at 6 months	Evolution of androstenedione level in patients with PCOS after 6 months therapy	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	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.	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.	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.	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.	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.	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.	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.	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.	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	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Margan Biotech
• Collaborators: Grupo CINUSA (Centros de Investigación en Nutrición y Salud S.L.)

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2020
• Primary Completion (ACTUAL): February 2, 2022
• Study Completion (ACTUAL): February 2, 2022

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral
• Other Study ID Numbers: SOP-DIET

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No