Home
Clinical Trials
Effects of Inositol Alone or ...

Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-07

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this double-blinded, three-armed randomized controlled trial (RCT) is to evaluate the effects of a 6 months treatment with inositol alone or inositol associated with alpha-lipoic acid in women with polycystic ovary syndrome (PCOS).

The study population is composed of 90 women with PCOS (diagnosed according to the Rotterdam criteria). Subjects are randomized to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone).

At recruitment and after 6 months of treatment, the following data are collected:

* clinical data: height, weight, BMI, waist and hip circumference, blood pressure, Ferriman Gallwey Score, menstrual diary
* endocrine parameters (serum total and free testosterone levels, SHBG levels)
* metabolic profile: glycemia and insulinemia at fasting and after oral glucose tolerance test (OGTT), serum lipids
* insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp and surrogate indexes
* ovarian ultrasound data. Furthermore, ovulation is evaluated from the 2nd to the 6th month of the study through progesterone serial dosages on weekly urinary samples.

The primary outcome of the study is the serum free testosterone variation after 6 months of treatment. Secondary outcomes are the variations of lipid profile, ovarian morphology and insulin-sensitivity after 6 months and the number of ovulations occurring in the last 4 months of treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females

NCT06418347

Polycystic Ovary Syndrome Infertility, Female

RECRUITING PHASE3

Myo-inositol Plus Alpha-lactalbumin in PCOS Myo-inositol-resistant Patients

NCT03667443

PCOS Myo-inositol-resistance

COMPLETED NA

Improved Effects of MI Plus Alpha-LA in PCOS

NCT03422289

Polycystic Ovary Syndrome

COMPLETED NA

Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate

NCT05231980

Clomiphene Citrate Resistant Ovary Syndrome Polycystic Ovary Syndrome

COMPLETED PHASE2

Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone

NCT01555190

Polycystic Ovary Syndrome Hirsutism Menstrual Irregularity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of this study is to evaluate the effects of a 6 months treatment with inositol, alone or associated with alpha-lipoic acid, in women with PCOS. This is a double blinded, three-armed RCT.

The study population is composed of 90 women with PCOS, recruited at the Department of Endocrinology and Metabolic Disease of Azienda Ospedaliera Universitaria Integrata (AOUI), Verona.

After recruitment, subjects are randomly assigned to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone). Randomisation is stratified by BMI category (3 categories 18\<BMI\<25, 25≥BMI\<30, 30≥BMI\<35 Kg/m2); randomisation list is generated by the statistical software Stata 13.1.

At baseline and after 6 months of treatment, the following data are collected:

* clinical examination: family and personal medical history, menstrual diary, physical examination including height, weight, waist and hip circumferences, blood pressure and hirsutism score (modified Ferriman-Gallwey score)
* total and free testosterone and sex hormone binding globulin (SHBG) blood levels, evaluated in the early follicular phase or after 3 months of amenorrhea
* metabolic profile: glycemia and insulinemia at fasting and after 2h OGTT, serum lipids (total cholesterol, HDL-cholesterol and triglycerides). Glycemia and insulinemia values during OGTT will be used to calculate surrogate indexes of insulin resistance
* insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp technique. Data obtained with this test will be normalized for lean mass, measured by bioelectrical impedance. The hyperinsulinemic-euglycemic clamp is repeated after 6 months of treatment only in subjects who are insulin-resistant at baseline (M-value \< 8.6 mg/kg min).
* Chronic inflammation markers (CRP)
* Ovarian ultrasound evaluation, including measurement of the 3 diameters for ovarian volume calculation, and follicle count. The ultrasound examination will be executed by a gynaecologist at the Department of Gynaecology and Obstetrics at AOUI, Verona.

Furthermore, all the study participants are subjected to:

* ovulation assessment by serial progesterone dosages on weekly urinary samples. Patients are given numbered urine beakers and are instructed to collect night urine weekly, starting at the 3rd month of treatment and until the end of the study (17 samples).
* monitoring visits after 2 and 4 months of treatment, to evaluate therapy compliance and possible adverse events.

30 ml blood samples of the study participants will be preserved for 10 years. On these samples, further examinations will be considered if new important markers of PCOS will emerge in the future.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded, three-armed RCT

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inositol + alpha lipoic acid

Inositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner

Group Type EXPERIMENTAL