D-chiroinositol Administration in Hypogonadal Males

Lo.Li.Pharma

Status: Completed

Conditions: Sexual Dysfunction; Male Hypogonadism

Treatments: Dietary Supplement: D-chiroinositol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04708249

DCI_HYPOGONADAL_MALES

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 65 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

D-chiroinositol treatment

Experimental group

Treatment:

Dietary Supplement: D-chiroinositol