Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS

Not Applicable

Completed

• Conditions: Hirsutism; Menstrual Problem; Polycystic Ovary Syndrome

• Registration Number: NCT03673995
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-02
• Primary Completion: 2018-08-22
• Study First Submitted: 2018-08-22
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Study Completion: 2018-10-30
• Last Update Submitted: 2020-06-13
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 186

Inclusion Criteria

° PCOS patients

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Restore of regular menstrual period	6 months of treatment	Self report

Secondary Outcome Measures

Name	Time	Method
Improving hirsutism	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,
Restore ovulation	6 months of treatment	Progesterone value in luteal phase

Trial Locations

Locations (1)

Altamedica Reproductive Medicine; 🇮🇹 Roma, Italy