Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS

June 13, 2020 updated by: Pharmarte srl

Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women

PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Most of them during the treatment improved their symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

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
      • Roma, Italy, 00198
        • Altamedica Reproductive Medicine

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

16 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

° PCOS patients

Exclusion Criteria:

  • thyroid dysfunction
  • hyperprolactinemia
  • adrenal hyperplasia
  • patients taking oral contraceptive
  • any other endocrinological pathologies

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: Myo-inositol+L-tyrosine
One sachet per day containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid for improving PCOS symptoms.
Dietary supplement: Myo-inositol+L-tyrosine
PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restore of regular menstrual period
Time Frame: 6 months of treatment
Self report
6 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improving hirsutism
Time Frame: 6 months of treatment
Standardised visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥ 4 - 6 indicating hirsutism,
6 months of treatment
Restore ovulation
Time Frame: 6 months of treatment
Progesterone value in luteal phase
6 months of treatment

Collaborators and Investigators

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

Sponsor

Pharmarte srl

Investigators

  • Principal Investigator: Mario Montanino Oliva, M.D., Altamedica Reproductive Medicine

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)

May 2, 2017

Primary Completion (Actual)

August 22, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 13, 2020

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PharmarteLtyrosine1

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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