Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women

January 7, 2016 updated by: Rosanna Apa, Catholic University of the Sacred Heart

Effects of Combined Therapy With Myo-inositol and Alpha-Lipoic Acid on Clinical, Endocrine and Metabolic Features in Women Affected by Polycystic Ovary Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of cycles in six months of therapy
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hirsutism
Time Frame: 6 months
Ferriman Gallwey score
6 months
Hyperandrogenism
Time Frame: 6 months
Testosterone, Androstenedione, free androgen index
6 months
Insulin response to oral glucose tolerance test
Time Frame: 6 months
6 months
Lipidic profile
Time Frame: 6 months
Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000102014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Clinical Trials on myo-inositol,alpha-lipoic acid and folic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe