Clinical trial NCT04708249: D-chiroinositol Administration in Hypogonadal Males
Official title: D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Hypogonadism
Sexual Dysfunction
Keywords: Male Hypogonadism
Testosterone
Aromatase
D-chiroinositol
Sexual dysfunction
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 10
Sex: MALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline Serum Testosterone at 1 month
timeFrame: At baseline and after 30 days of treatment
Secondary outcomes:
measure: Change from Baseline Weight at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline Waist circumference at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline BMI at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline Insulin at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline Glycaemia at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline HOMA index at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline Androstenedione at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline Luteinizing Hormone at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline Oestradiol at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline Oestrone at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline Testosterone/Oestradiol ratio at 1 month
timeFrame: At baseline and after 30 days of treatment
measure: Change from Baseline Strength Test at 1 month
timeFrame: At baseline and after 30 days of treatment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Clinica Alma Res
Study officials:
References:
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.