Improved Effects of MI Plus Alpha-LA in PCOS

February 5, 2018 updated by: Lo.Li.Pharma s.r.l

Improved Effects of Myo-inositol in Association With Alpha-lactalbumin in PCOS Women

PCOS patients are initially treated with 2 g myo-inositol and 0.2 mg folic acid, two times per day by oral route, for three months. Among them, the subjects who have not ovulated despite this treatment are administered with 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. Most of them improve and achieve ovulation. Therefore, the combination of α-lactalbumin with myo-inositol allows to get a significant result in the treatment of PCOS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Polycystic ovary syndrome is a complex chronic condition inducing several related disorders, such as subfertility and pregnancy complications. So far myo-inositol, successfully used in PCOS, has not been always effective in all patients. Aiming at overcoming this drawback, we tested a new formulation with myo-inositol and α-lactalbumin, in consideration of the effects exerted by α-lactalbumin in favoring molecule passage among body compartments, and also in consideration of its anti-inflammatory activity.

Only PCOS patients, according to Rotterdam ESHRE-ASRM criteria, with anovulation and infertility > 1 year, were included in the study. Following a treatment with 2 g myo-inositol and 0.2 mg folic acid, a part of them are resistant and do not ovulate.

These non-responders to myo-inositol alone undergo the second phase of the study, receiving 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. After this combined treatment, the majority of them ovulate, showing a hormone and lipid profile improvement. In addition, myo-inositol plasma levels at the end of the treatment are significantly higher than at baseline and comparable to those patients who respond positively to myo-inositol alone.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy
        • Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital

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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients affected by PCOS according to Rotterdam ESHRE-ASRM criteria, with anovulation and infertility > 1 year

Exclusion Criteria:

  • presence of other conditions causing ovulatory dysfunction, such as hyperprolactinemia or hypothyroidism, or androgen excess, such as adrenal hyperplasia or Cushing's syndrome, and also in the case of intake of other drugs that can potentially influence the ovulation.

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myo-inositol + folic acid
2 g myo-inositol and 0.2 mg folic acid orally twice a day for three months, in order to induce ovulation.
Dietary supplement: myo-inositol plus folic acid
this treatment is made in the first phase of the study for three months
Experimental: Myo-inositol + folic a. + α-lactalbumin
2 g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin, twice a day for three months in order to test if α-lactalbumin addition allows to induce ovulation
Dietary supplement: myo-inositol plus folic acid plus alpha-lactalbumin
this treatment is made in the second phase of the study and it has a new molecule added to the previous ones administered in the first phase of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration of ovulation
Time Frame: after three months of treatment
Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle.
after three months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of myo-inositol plasma levels after the treatment with myo-inositol plus alpha-lactalbumin compared to the levels at the baseline
Time Frame: after three months of treatment
Myo-inositol was dosed in plasma by means of gas chromatography-mass spectrometry
after three months of treatment

Collaborators and Investigators

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

Sponsor

Lo.Li.Pharma s.r.l

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 2, 2016

Primary Completion (Actual)

October 12, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI + alpha-LA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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