search
Back to results

D-chiroinositol Administration in Hypogonadal Males

Primary Purpose

Male Hypogonadism, Sexual Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
D-chiroinositol
Sponsored by
Lo.Li.Pharma s.r.l
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Hypogonadism focused on measuring Male Hypogonadism, Testosterone, Aromatase, D-chiroinositol, Sexual dysfunction

Eligibility Criteria

65 Years - 75 Years (Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men, with a diagnosis of Late-Onset Male Hypogonadism
  • Insulin resistance (HOMA Index > 2,5)
  • BMI between 25 and 30

Exclusion Criteria:

  • Alcohol intake and/or drug abuse
  • Recent hormonal treatment
  • Smoking
  • Obesity
  • Systemic or endocrine diseases
  • Male accessory gland infection
  • Clinical history of cryptorchidism or varicocele and micro-orchidism

Sites / Locations

  • Clinica Alma Res

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

D-chiroinositol treatment

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline Serum Testosterone at 1 month
Level of testosterone detected in the blood in ng/dL

Secondary Outcome Measures

Change from Baseline Weight at 1 month
Body weight of patients reported in kg
Change from Baseline Waist circumference at 1 month
Waist circumference of patients reported in cm
Change from Baseline BMI at 1 month
Body Mass Index of patients calculated as kg/m2, where kg is the weight measured for eah patient while m2 is his height squared
Change from Baseline Insulin at 1 month
Level of fasting insulin detected in the blood and reported in microU/L
Change from Baseline Glycaemia at 1 month
Level of fasting glycaemia detected in the blood and reported in mg/dL
Change from Baseline HOMA index at 1 month
HOMA index known as Homeostatic Model Assessment for Insulin Resistance is: (fasting glycaemia x fasting insulin)/405
Change from Baseline Androstenedione at 1 month
Level of androstenedione detected in the blood and reported in ng/mL
Change from Baseline Luteinizing Hormone at 1 month
Level of luteinizing hormone detected in the blood and reported in mUI/ml
Change from Baseline Oestradiol at 1 month
Level of oestradiol detected in the blood and reported in pg/mL
Change from Baseline Oestrone at 1 month
Level of oestrone detected in the blood and reported in pg/mL
Change from Baseline Testosterone/Oestradiol ratio at 1 month
Ratio between the levels of oestradiol and testosterone detected in the blood
Change from Baseline Strength Test at 1 month
Measurement of strength performed with the dominant hand using a hand-held dynamometer (Good Strength, IGS01, Metitur Oy, Jyväskylä, Finland) with the participant in the seated position with elbow flexed at 110°. The participant will be instructed to squeeze the handle as hard as possible for 3-5 seconds and the stregth will be recorded in kg

Full Information

First Posted
January 8, 2021
Last Updated
March 1, 2021
Sponsor
Lo.Li.Pharma s.r.l
search

1. Study Identification

Unique Protocol Identification Number
NCT04708249
Brief Title
D-chiroinositol Administration in Hypogonadal Males
Official Title
D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In this regard, DCI administration in case of reduced levels of testosterone, could be a good therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH) in undoubtedly an interesting target. LOH is a reduction of testosterone level due to advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately, there is a lack of information about TRT safety, especially in older men. For these reasons, the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation in LOH patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Hypogonadism, Sexual Dysfunction
Keywords
Male Hypogonadism, Testosterone, Aromatase, D-chiroinositol, Sexual dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-chiroinositol treatment
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
D-chiroinositol
Intervention Description
Supplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days.
Primary Outcome Measure Information:
Title
Change from Baseline Serum Testosterone at 1 month
Description
Level of testosterone detected in the blood in ng/dL
Time Frame
At baseline and after 30 days of treatment
Secondary Outcome Measure Information:
Title
Change from Baseline Weight at 1 month
Description
Body weight of patients reported in kg
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline Waist circumference at 1 month
Description
Waist circumference of patients reported in cm
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline BMI at 1 month
Description
Body Mass Index of patients calculated as kg/m2, where kg is the weight measured for eah patient while m2 is his height squared
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline Insulin at 1 month
Description
Level of fasting insulin detected in the blood and reported in microU/L
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline Glycaemia at 1 month
Description
Level of fasting glycaemia detected in the blood and reported in mg/dL
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline HOMA index at 1 month
Description
HOMA index known as Homeostatic Model Assessment for Insulin Resistance is: (fasting glycaemia x fasting insulin)/405
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline Androstenedione at 1 month
Description
Level of androstenedione detected in the blood and reported in ng/mL
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline Luteinizing Hormone at 1 month
Description
Level of luteinizing hormone detected in the blood and reported in mUI/ml
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline Oestradiol at 1 month
Description
Level of oestradiol detected in the blood and reported in pg/mL
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline Oestrone at 1 month
Description
Level of oestrone detected in the blood and reported in pg/mL
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline Testosterone/Oestradiol ratio at 1 month
Description
Ratio between the levels of oestradiol and testosterone detected in the blood
Time Frame
At baseline and after 30 days of treatment
Title
Change from Baseline Strength Test at 1 month
Description
Measurement of strength performed with the dominant hand using a hand-held dynamometer (Good Strength, IGS01, Metitur Oy, Jyväskylä, Finland) with the participant in the seated position with elbow flexed at 110°. The participant will be instructed to squeeze the handle as hard as possible for 3-5 seconds and the stregth will be recorded in kg
Time Frame
At baseline and after 30 days of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men, with a diagnosis of Late-Onset Male Hypogonadism Insulin resistance (HOMA Index > 2,5) BMI between 25 and 30 Exclusion Criteria: Alcohol intake and/or drug abuse Recent hormonal treatment Smoking Obesity Systemic or endocrine diseases Male accessory gland infection Clinical history of cryptorchidism or varicocele and micro-orchidism
Facility Information:
Facility Name
Clinica Alma Res
City
Rome
ZIP/Postal Code
00198
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34763665
Citation
Nordio M, Kumanov P, Chiefari A, Puliani G. D-Chiro-Inositol improves testosterone levels in older hypogonadal men with low-normal testosterone: a pilot study. Basic Clin Androl. 2021 Nov 12;31(1):28. doi: 10.1186/s12610-021-00146-4.
Results Reference
derived

Learn more about this trial

D-chiroinositol Administration in Hypogonadal Males

We'll reach out to this number within 24 hrs