NCT02651636

Brief Summary

The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose tolerance test, lipidic profile at baseline and after six months of treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

November 27, 2015

Last Update Submit

January 7, 2016

Conditions

Polycystic Ovary SyndromeMenstrual PatternHyperandrogenismMetabolic Features

Outcome Measures

Primary Outcomes (1)

  • Number of cycles in six months of therapy

    6 months

Secondary Outcomes (4)

  • Hirsutism

    6 months

  • Hyperandrogenism

    6 months

  • Insulin response to oral glucose tolerance test

    6 months

  • Lipidic profile

    6 months

Study Arms (1)

Open label

EXPERIMENTAL

Therapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months

Drug: myo-inositol,alpha-lipoic acid and folic acid

Interventions

myo-inositol,alpha-lipoic acid and folic acidDRUG
Open label

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with PCOS in accordance with Rotterdam criteria

You may not qualify if:

  • pregnancy
  • past history of cardiovascular disease,
  • diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test),
  • hypertension,
  • significant liver or renal impairment,
  • other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs),
  • neoplasms,
  • unstable mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary SyndromeHyperandrogenism

Interventions

InositolThioctic AcidFolic Acid

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesCarboxylic AcidsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipidsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 27, 2015

First Posted

January 11, 2016

Study Start

June 1, 2014

Primary Completion

July 1, 2015

Last Updated

January 11, 2016

Record last verified: 2016-01