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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03673995
Other study ID # PharmarteLtyrosine1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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