NCT03673995

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

June 16, 2020

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

August 22, 2018

Last Update Submit

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

EXPERIMENTAL

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

Interventions

Myo-inositol+L-tyrosineDIETARY_SUPPLEMENT

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.

Myo-inositol+L-tyrosine

Eligibility Criteria

Age16 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Altamedica Reproductive Medicine

Roma, 00198, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeMenstruation DisturbancesHirsutism

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and Symptoms

Study Officials

  • Mario Montanino Oliva, M.D.

    Altamedica Reproductive Medicine

    PRINCIPAL INVESTIGATOR

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

Locations