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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Metionac
Oral contraceptive
Sponsored by
Margan Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital Quironsalud San José

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Oral Contraceptive

Oral Contraceptive + Food supplement Metionac

Food supplement MetioNac

Arm Description

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

Outcomes

Primary Outcome Measures

Change from Baseline in the Mean BMI at 6 Months
Evolution of Body Mass Index in patients with PCOS after 6 months therapy
Change from Baseline in the Mean Insuline level at 6 Months
Evolution of Insuline level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean Glucose level at 6 Months
Evolution of Glucose level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean Triglycerides at 6 Months
Evolution of Triglycerides level in patients with PCOS after 6 months therapy
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.
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
Change from Baseline in the Mean AST at 6 months
Evolution of aspartate aminotransferase (AST) level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean ALT at 6 months
Evolution of alanine aminotransferase (ALT) level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean GGT at 6 months
Evolution of gamma glutamyltransferase (GGT) level in patients with PCOS after 6 months therapy
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

Secondary Outcome Measures

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
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
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
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
Change from Baseline in the Mean Testosterone at 6 months
Evolution of testosterone level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean Androstenedione at 6 months
Evolution of androstenedione level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean DHEA at 6 months
Evolution of Dehydroepiandrosterone (DHEA) level in patients with PCOS after 6 months therapy
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.
Change from Baseline in the Mean Homocysteine at 6 months
Evolution of homocysteine (HC) level in patients with PCOS after 6 months therapy.
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.
Change from Baseline in the Mean Hb A1c at 6 months
Evolution of hemoglobin A1c in patients with PCOS after 6 months therapy.
Change from Baseline in the Mean SHBG at 6 months
Evolution of sex hormone binding globulin in patients with PCOS after 6 months therapy.
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.
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.
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.
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
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.
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.

Full Information

First Posted
April 17, 2022
Last Updated
April 21, 2022
Sponsor
Margan Biotech
Collaborators
Grupo CINUSA (Centros de Investigación en Nutrición y Salud S.L.)
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1. Study Identification

Unique Protocol Identification Number
NCT05340634
Brief Title
Evaluation of Metionac for the Modulation of Metabolic and Endocrine Parameters in Patients With PCOS.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
February 2, 2022 (Actual)
Study Completion Date
February 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Margan Biotech
Collaborators
Grupo CINUSA (Centros de Investigación en Nutrición y Salud S.L.)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Contraceptive
Arm Type
Active Comparator
Arm Description
Drospirenone 4 mg once a day for 6 months
Arm Title
Oral Contraceptive + Food supplement Metionac
Arm Type
Experimental
Arm 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
Arm Title
Food supplement MetioNac
Arm Type
Other
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Metionac
Intervention Description
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
Drug
Intervention Name(s)
Oral contraceptive
Intervention Description
Drospirenone 4 mg once a day
Primary Outcome Measure Information:
Title
Change from Baseline in the Mean BMI at 6 Months
Description
Evolution of Body Mass Index in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean Insuline level at 6 Months
Description
Evolution of Insuline level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean Glucose level at 6 Months
Description
Evolution of Glucose level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean Triglycerides at 6 Months
Description
Evolution of Triglycerides level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean HDL at 6 Months
Description
Evolution of high-density lipoprotein (HDL) cholesterol level in patients with PCOS after 6 months therapy.
Time Frame
6 months
Title
Change from Baseline in the Mean LDL at 6 Months
Description
Evolution of low-density lipoprotein (LDL) level in patients with PCOS after 6 months therapy
Time Frame
6 monhts
Title
Change from Baseline in the Mean AST at 6 months
Description
Evolution of aspartate aminotransferase (AST) level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean ALT at 6 months
Description
Evolution of alanine aminotransferase (ALT) level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean GGT at 6 months
Description
Evolution of gamma glutamyltransferase (GGT) level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean Bilirubin at 6 Months
Description
Evolution of total and free bilirubin level in patients with PCOS after 6 months therapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Description
Evolution of 17 beta estradiol level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
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
Description
Evolution of 17 hydroxy progesterone level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
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
Description
Evolution of luteinizing hormone (LH) level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
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
Description
Evolution of follicle-stimulating hormone (FSH) level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean Testosterone at 6 months
Description
Evolution of testosterone level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean Androstenedione at 6 months
Description
Evolution of androstenedione level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean DHEA at 6 months
Description
Evolution of Dehydroepiandrosterone (DHEA) level in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean TSH at 6 months
Description
Evolution of thyroid stimulating hormone (TSH) level in patients with PCOS after 6 months therapy.
Time Frame
6 months
Title
Change from Baseline in the Mean Homocysteine at 6 months
Description
Evolution of homocysteine (HC) level in patients with PCOS after 6 months therapy.
Time Frame
6 months
Title
Change from Baseline in the Mean HOMA-IR at 6 months
Description
Evolution of HOMA insulin resistance level in patients with PCOS after 6 months therapy.
Time Frame
6 months
Title
Change from Baseline in the Mean Hb A1c at 6 months
Description
Evolution of hemoglobin A1c in patients with PCOS after 6 months therapy.
Time Frame
6 months
Title
Change from Baseline in the Mean SHBG at 6 months
Description
Evolution of sex hormone binding globulin in patients with PCOS after 6 months therapy.
Time Frame
6 months
Title
Change from Baseline in the Mean Hirsutism score at 6 months
Description
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
Title
Change from Baseline in the Mean Acne self-assessment score at 6 months
Description
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
Title
Change from Baseline in the Mean Alopecia score at 6 months
Description
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
Title
Change from Baseline in the Proportion of patients with irregular menstrual cycle at 6 months
Description
Regularization of irregular menstrual cycle in patients with PCOS after 6 months therapy
Time Frame
6 months
Title
Change from Baseline in the Mean Migraine score at 6 months
Description
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
Title
Change from Baseline in the Mean QoL score at 6 months
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 > 18 years old Overweight defined as BMI>25 Normal prolactin levels 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) Written inform consent Exclusion Criteria: Diabetic women Adrenal enzyme deficiency and/or other endocrine disease Pregnant or lactating women. Women under treatment with SNRIs (serotonin reuptake inhibitors) Other serious illness
Facility Information:
Facility Name
Hospital Quironsalud San José
City
Madrid
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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