Skip to main content
OpenTrials
Completed

NCT Number: NCT04708249

D-chiroinositol Administration in Hypogonadal Males

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Male Hypogonadism Endocrine System Diseases Eunuchism Genital Diseases Gonadal Disorders Hypogonadism Sexual Dysfunction Sexual Dysfunction, Physiological Urogenital Diseases

Age range

65 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Alma Res

Rome, 00198, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-chiroinositol

Dietary Supplement

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

Primary outcomes

  1. Change from Baseline Serum Testosterone at 1 month

    Time frame: At baseline and after 30 days of treatment

    Level of testosterone detected in the blood in ng/dL

Secondary outcomes

  1. Change from Baseline Weight at 1 month

    Time frame: At baseline and after 30 days of treatment

    Body weight of patients reported in kg

  2. Change from Baseline Waist circumference at 1 month

    Time frame: At baseline and after 30 days of treatment

    Waist circumference of patients reported in cm

  3. Change from Baseline BMI at 1 month

    Time frame: At baseline and after 30 days of treatment

    Body Mass Index of patients calculated as kg/m2, where kg is the weight measured for eah patient while m2 is his height squared

  4. Change from Baseline Insulin at 1 month

    Time frame: At baseline and after 30 days of treatment

    Level of fasting insulin detected in the blood and reported in microU/L

  5. Change from Baseline Glycaemia at 1 month

    Time frame: At baseline and after 30 days of treatment

    Level of fasting glycaemia detected in the blood and reported in mg/dL

  6. Change from Baseline HOMA index at 1 month

    Time frame: At baseline and after 30 days of treatment

    HOMA index known as Homeostatic Model Assessment for Insulin Resistance is: (fasting glycaemia x fasting insulin)/405

  7. Change from Baseline Androstenedione at 1 month

    Time frame: At baseline and after 30 days of treatment

    Level of androstenedione detected in the blood and reported in ng/mL

  8. Change from Baseline Luteinizing Hormone at 1 month

    Time frame: At baseline and after 30 days of treatment

    Level of luteinizing hormone detected in the blood and reported in mUI/ml

  9. Change from Baseline Oestradiol at 1 month

    Time frame: At baseline and after 30 days of treatment

    Level of oestradiol detected in the blood and reported in pg/mL

  10. Change from Baseline Oestrone at 1 month

    Time frame: At baseline and after 30 days of treatment

    Level of oestrone detected in the blood and reported in pg/mL

  11. Change from Baseline Testosterone/Oestradiol ratio at 1 month

    Time frame: At baseline and after 30 days of treatment

    Ratio between the levels of oestradiol and testosterone detected in the blood

  12. Change from Baseline Strength Test at 1 month

    Time frame: At baseline and after 30 days of treatment

    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

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.