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Polycystic Ovary SyndromePhase 4NCT05340634

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

A Phase 4 study testing Metionac and Oral contraceptive in people with Polycystic Ovary Syndrome, run by Margan Biotech at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Metionac and Oral contraceptive
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSpain
Study dates
20 Apr 2020to 2 Feb 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • > 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Quironsalud San José

    Madrid

Other trials in Spain

About this study

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.

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.

Read the 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).

Being tested
Metionac, Oral contraceptive
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05340634
Study groupRoleWhat they receive
Oral ContraceptiveActive comparatorDrospirenone 4 mg once a day for 6 months
Receives: Drug: Oral contraceptive
Oral Contraceptive + Food supplement MetionacExperimentalDrospirenone 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
Receives: Dietary Supplement: Metionac; Drug: Oral contraceptive
Food supplement MetioNacOtherMetionac twice daily (200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg alpha lipoid acid and 0,65 Vitamin B6) for 6 months
Receives: Dietary Supplement: Metionac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Mean BMI at 6 Months

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

    Measured: 6 months

  2. Change from Baseline in the Mean Insuline level at 6 Months

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

    Measured: 6 months

  3. Change from Baseline in the Mean Glucose level at 6 Months

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

    Measured: 6 months

  4. Change from Baseline in the Mean Triglycerides at 6 Months

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

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. 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

    Measured: 6 monhts

  7. Change from Baseline in the Mean AST at 6 months

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

    Measured: 6 months

  8. Change from Baseline in the Mean ALT at 6 months

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

    Measured: 6 months

  9. Change from Baseline in the Mean GGT at 6 months

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

    Measured: 6 months

  10. 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

    Measured: 6 months

Secondary outcomes (18)

  1. 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

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. Change from Baseline in the Mean Testosterone at 6 months

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

    Measured: 6 months

  6. Change from Baseline in the Mean Androstenedione at 6 months

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

    Measured: 6 months

  7. Change from Baseline in the Mean DHEA at 6 months

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

    Measured: 6 months

  8. 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.

    Measured: 6 months

  9. Change from Baseline in the Mean Homocysteine at 6 months

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

    Measured: 6 months

  10. 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.

    Measured: 6 months

  11. Change from Baseline in the Mean Hb A1c at 6 months

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

    Measured: 6 months

  12. Change from Baseline in the Mean SHBG at 6 months

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

    Measured: 6 months

  13. 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.

    Measured: 6 months

  14. 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.

    Measured: 6 months

  15. 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.

    Measured: 6 months

  16. 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

    Measured: 6 months

  17. 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.

    Measured: 6 months

  18. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start20 Apr 2020
  3. Primary completion2 Feb 2022
  4. Study completion2 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05340634
Sponsor's protocol ID
SOP-DIET
Status last verified
Apr 2022
First submitted
17 Apr 2022
Last updated
28 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metionac and Oral contraceptive in people with Polycystic Ovary Syndrome, run by Margan Biotech at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Mean BMI at 6 Months (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05340634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.

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