Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS
Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women
1 other identifier
interventional
186
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2017
CompletedFirst Submitted
Initial submission to the registry
August 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2018
CompletedFirst Posted
Study publicly available on registry
September 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedJune 16, 2020
September 1, 2018
1.3 years
August 22, 2018
June 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Restore of regular menstrual period
Self report
6 months of treatment
Secondary Outcomes (2)
Improving hirsutism
6 months of treatment
Restore ovulation
6 months of treatment
Study Arms (1)
Myo-inositol+L-tyrosine
EXPERIMENTALOne 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- ° PCOS patients
You may not qualify if:
- thyroid dysfunction
- hyperprolactinemia
- adrenal hyperplasia
- patients taking oral contraceptive
- any other endocrinological pathologies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmarte srllead
Study Sites (1)
Altamedica Reproductive Medicine
Roma, 00198, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Montanino Oliva, M.D.
Altamedica Reproductive Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2018
First Posted
September 17, 2018
Study Start
May 2, 2017
Primary Completion
August 22, 2018
Study Completion
October 30, 2018
Last Updated
June 16, 2020
Record last verified: 2018-09