D-chiroinositol Administration in Hypogonadal Males

Sexual Dysfunction Clinical Trial

Official title:

D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708249
• Other study ID #: DCI_HYPOGONADAL_MALES
• Status: Completed
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: March 1, 2021

Study information

• Verified date: January 2021
• Source: Lo.Li.Pharma s.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism
• Male Hypogonadism
• Sexual Dysfunction

Intervention

Dietary Supplement:
• D-chiroinositol
Supplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days.

Locations

Country	Name	City	State
Italy	Clinica Alma Res	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Serum Testosterone at 1 month	Level of testosterone detected in the blood in ng/dL	At baseline and after 30 days of treatment
Secondary	Change from Baseline Weight at 1 month	Body weight of patients reported in kg	At baseline and after 30 days of treatment
Secondary	Change from Baseline Waist circumference at 1 month	Waist circumference of patients reported in cm	At baseline and after 30 days of treatment
Secondary	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	At baseline and after 30 days of treatment
Secondary	Change from Baseline Insulin at 1 month	Level of fasting insulin detected in the blood and reported in microU/L	At baseline and after 30 days of treatment
Secondary	Change from Baseline Glycaemia at 1 month	Level of fasting glycaemia detected in the blood and reported in mg/dL	At baseline and after 30 days of treatment
Secondary	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	At baseline and after 30 days of treatment
Secondary	Change from Baseline Androstenedione at 1 month	Level of androstenedione detected in the blood and reported in ng/mL	At baseline and after 30 days of treatment
Secondary	Change from Baseline Luteinizing Hormone at 1 month	Level of luteinizing hormone detected in the blood and reported in mUI/ml	At baseline and after 30 days of treatment
Secondary	Change from Baseline Oestradiol at 1 month	Level of oestradiol detected in the blood and reported in pg/mL	At baseline and after 30 days of treatment
Secondary	Change from Baseline Oestrone at 1 month	Level of oestrone detected in the blood and reported in pg/mL	At baseline and after 30 days of treatment
Secondary	Change from Baseline Testosterone/Oestradiol ratio at 1 month	Ratio between the levels of oestradiol and testosterone detected in the blood	At baseline and after 30 days of treatment
Secondary	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	At baseline and after 30 days of treatment