NCT05340634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

April 17, 2022

Last Update Submit

April 21, 2022

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (18)

  • 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

    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

    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

    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

    6 months

  • Change from Baseline in the Mean Testosterone at 6 months

    6 months

  • +13 more secondary outcomes

Study Arms (3)

Oral Contraceptive

ACTIVE COMPARATOR

Drospirenone 4 mg once a day for 6 months

Drug: Oral contraceptive

Oral Contraceptive + Food supplement Metionac

EXPERIMENTAL

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

Dietary Supplement: MetionacDrug: Oral contraceptive

Food supplement MetioNac

OTHER

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

Interventions

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

Food supplement MetioNacOral Contraceptive + Food supplement Metionac
Oral contraceptiveDRUG

Drospirenone 4 mg once a day

Oral ContraceptiveOral Contraceptive + Food supplement Metionac

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Quironsalud San José

Madrid, Spain

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 22, 2022

Study Start

April 20, 2020

Primary Completion

February 2, 2022

Study Completion

February 2, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

ES(1)