Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02666170
NCT02666170UnknownNot Applicable

Effects of 6 Months of Alpha-Lipoic Acid Treatment on Clinical, Endocrine ed Metabolic Features in Women Affected by PCOS

Catholic University of the Sacred Heart0 sites40 target enrollmentStarted: January 2016Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Primary Endpoint
Number of cycles in six months of therapy
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria

  • •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.

Arms & Interventions

therapy with alpha-lipoic acid daily for six months

Experimental

Intervention: Alpha-lipoic acid (Drug)

Outcomes

Primary Outcomes

Number of cycles in six months of therapy

Time Frame: 6 months

Secondary Outcomes

  • Hirsutism score(6 months)
  • Insulin levels(6 months)
  • androstenedione levels(6 months)
  • testosterone levels(6 months)
  • free androgen index(6 months)
  • LDL-cholesterol(6 months)
  • total cholesterol(6 months)
  • tryglycerides levels(6 months)
  • DHEAS levels(6 months)
  • AMH levels(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rosanna Apa

Professor

Catholic University of the Sacred Heart

Similar Trials

Completed
Not Applicable
Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute ExerciseG6PD Deficiency
NCT02937363University of Thessaly10
Completed
Phase 4
The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic NeuropathyCardiac Autonomic NeuropathyType 2 Diabetes
NCT02056366The Catholic University of Korea91
Terminated
Not Applicable
The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic RetinopathyModerate Non-proliferative Diabetic Retinopathy
NCT01880372Ferris State University1
Completed
Phase 2
Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Carpal Tunnel Syndrome Undergoing Surgical ReleaseCarpal Tunnel Syndrome
NCT02382328Hospital Civil de Guadalajara40
Completed
Not Applicable
Alpha Lipoic Acid Effect on No-Reflow PhenomenonNo-Reflow Phenomenon
NCT05360602Ain Shams University70