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Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS

Primary Purpose

Polycystic Ovary Syndrome, Menstrual Problem, Hirsutism

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Myo-inositol+L-tyrosine
Sponsored by
Pharmarte srl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

16 Years - 38 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

° PCOS patients

Exclusion Criteria:

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

Sites / Locations

  • Altamedica Reproductive Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Myo-inositol+L-tyrosine

Arm Description

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.

Outcomes

Primary Outcome Measures

Restore of regular menstrual period
Self report

Secondary Outcome Measures

Improving hirsutism
Standardised visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥ 4 - 6 indicating hirsutism,
Restore ovulation
Progesterone value in luteal phase

Full Information

First Posted
August 22, 2018
Last Updated
June 13, 2020
Sponsor
Pharmarte srl
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1. Study Identification

Unique Protocol Identification Number
NCT03673995
Brief Title
Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS
Official Title
Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmarte srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Menstrual Problem, Hirsutism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myo-inositol+L-tyrosine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol+L-tyrosine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Restore of regular menstrual period
Description
Self report
Time Frame
6 months of treatment
Secondary Outcome Measure Information:
Title
Improving hirsutism
Description
Standardised visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥ 4 - 6 indicating hirsutism,
Time Frame
6 months of treatment
Title
Restore ovulation
Description
Progesterone value in luteal phase
Time Frame
6 months of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ° PCOS patients Exclusion Criteria: thyroid dysfunction hyperprolactinemia adrenal hyperplasia patients taking oral contraceptive any other endocrinological pathologies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Montanino Oliva, M.D.
Organizational Affiliation
Altamedica Reproductive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altamedica Reproductive Medicine
City
Roma
ZIP/Postal Code
00198
Country
Italy

12. IPD Sharing Statement

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Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS

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