Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673995
• Other study ID #: PharmarteLtyrosine1
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: September 2018
• Source: Pharmarte srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: October 30, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 38 Years

Eligibility

Inclusion Criteria:

° PCOS patients

Exclusion Criteria:

• thyroid dysfunction

• hyperprolactinemia

• adrenal hyperplasia

• patients taking oral contraceptive

• any other endocrinological pathologies

Related Conditions & MeSH terms

• Hirsutism
• Menstrual Problem
• Menstruation Disturbances
• Polycystic Ovary Syndrome

Intervention

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.

Locations

Country	Name	City	State
Italy	Altamedica Reproductive Medicine	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Pharmarte srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restore of regular menstrual period	Self report	6 months of treatment
Secondary	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,	6 months of treatment
Secondary	Restore ovulation	Progesterone value in luteal phase	6 months of treatment