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
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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
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
Learn more about this trial
Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS
We'll reach out to this number within 24 hrs