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Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03673995
Recruitment Status : Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmarte srl

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Menstrual Problem Hirsutism Dietary Supplement: Myo-inositol+L-tyrosine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : August 22, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Restore of regular mestrual period [ Time Frame: 6 months of treatment ]
    Self report


Secondary Outcome Measures :
  1. Improving Hyrsutism [ 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,

  2. Restore ovulation [ Time Frame: 6 months of treatment ]
    Progesterone value in luteal phase



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Ages Eligible for Study:   16 Years to 38 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

° PCOS patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673995


Locations
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Italy
Altamedica Reproductive Medicine
Roma, Italy, 00198
Sponsors and Collaborators
Pharmarte srl
Investigators
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Principal Investigator: Mario Montanino Oliva, M.D. Altamedica Reproductive Medicine

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Responsible Party: Pharmarte srl
ClinicalTrials.gov Identifier: NCT03673995     History of Changes
Other Study ID Numbers: PharmarteLtyrosine1
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
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Inositol
Polycystic Ovary Syndrome
Hirsutism
Menstruation Disturbances
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms
Pathologic Processes
Selenium
Chromium
Picolinic acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances
Vitamin B Complex
Vitamins