NCT02666170

Brief Summary

The aim of our study is to investigate the effects of six months treatment with alpha-lipoic acid on clinical, endocrine and metabolic features in women affected by PCOS. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian featureas, an oral glucose tolerance test and hormonal assays are evaluated before and after therapy.

Trial Health

50
Monitor

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
unknown

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

January 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

8 months

First QC Date

January 21, 2016

Last Update Submit

January 26, 2016

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of cycles in six months of therapy

    6 months

Secondary Outcomes (10)

  • Hirsutism score

    6 months

  • Insulin levels

    6 months

  • androstenedione levels

    6 months

  • testosterone levels

    6 months

  • free androgen index

    6 months

  • +5 more secondary outcomes

Study Arms (1)

therapy with alpha-lipoic acid daily for six months

EXPERIMENTAL
Drug: Alpha-lipoic acid

Interventions

Alpha-lipoic acidDRUG
therapy with alpha-lipoic acid daily for six months

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 diseases
  • diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
  • hypertension
  • significant liver or renal impairment
  • other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal)
  • neoplasms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

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

January 21, 2016

First Posted

January 28, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01