Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS

• Sponsor: Pharmarte srl (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03673995
• Collaborator: (none)
• Enrollment: 186
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 10.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Menstrual Problem; Hirsutism	Dietary Supplement: Myo-inositol+L-tyrosine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 186 participants
• Allocation: N/A
• 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: Aug 22, 2018
• Actual Study Completion Date: Oct 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Restore of regular menstrual period [6 months of treatment]

   Self report

Secondary Outcome Measures

1. 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,

2. Restore ovulation [6 months of treatment]

   Progesterone value in luteal phase

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

° PCOS patients

Exclusion Criteria:

• thyroid dysfunction

• hyperprolactinemia

• adrenal hyperplasia

• patients taking oral contraceptive

• any other endocrinological pathologies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altamedica Reproductive Medicine	Roma		Italy	00198

Sponsors and Collaborators

• Pharmarte srl

Investigators

• Principal Investigator: Mario Montanino Oliva, M.D., Altamedica Reproductive Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pharmarte srl
• ClinicalTrials.gov Identifier: NCT03673995
• Other Study ID Numbers: PharmarteLtyrosine1
• First Posted: Sep 17, 2018
• Last Update Posted: Jun 16, 2020
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Hirsutism; Menstruation Disturbances; Inositol

Study Results

No Results Posted as of Jun 16, 2020