Clinical trial NCT05340634: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Margan Biotech
Sponsor class: INDUSTRY
Collaborators: name: Grupo CINUSA (Centros de Investigación en Nutrición y Salud S.L.)
First posted: 2022-04-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in the Mean BMI at 6 Months
timeFrame: 6 months
measure: Change from Baseline in the Mean Insuline level at 6 Months
timeFrame: 6 months
measure: Change from Baseline in the Mean Glucose level at 6 Months
timeFrame: 6 months
measure: Change from Baseline in the Mean Triglycerides at 6 Months
timeFrame: 6 months
measure: Change from Baseline in the Mean HDL at 6 Months
timeFrame: 6 months
measure: Change from Baseline in the Mean LDL at 6 Months
timeFrame: 6 monhts
measure: Change from Baseline in the Mean AST at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean ALT at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean GGT at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean Bilirubin at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Change from Baseline in the Mean Testosterone at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean Androstenedione at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean DHEA at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean TSH at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean Homocysteine at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean HOMA-IR at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean Hb A1c at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean SHBG at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean Hirsutism score at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean Acne self-assessment score at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean Alopecia score at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Proportion of patients with irregular menstrual cycle at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean Migraine score at 6 months
timeFrame: 6 months
measure: Change from Baseline in the Mean QoL score at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Quironsalud San José
Study officials:
References: