Use of D-Chiro-inositol in Male Functional Hypogonadism Associated With Sexual Dysfunction

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07584772

Acronym

HERO_2025

Enrollment

Registered

2026-05-13

Start date

2026-07-01

Completion date

2027-01-01

Last updated

2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Hypogonadism

Brief summary

A prospective, uncontrolled, non-pharmacological interventional study conducted on men with functional or borderline hypogonadism, aimed at evaluating, after 3 months of supplementation with D-Chiro-inositol, changes in hormonal profile and sexual function.

Detailed description

The study involves the recruitment of 35 functional hypogonadal patients aged between 50 and 75 years to the Andrology Unit of the "Antonio Cardarelli" Hospital. At T0 patients will undergo hematochemical evaluation of the following parameters: total and free testosterone, PSA and hematocrit. At the same time, they will be provided with a self-assessment questionnaire on physical and sexual functioning. The same evaluations will be performed after 3 months of supplementation (T1). The main endpoint is the intra-subject variation in total and free testosterone levels between T0 and T1.

Interventions

DIETARY_SUPPLEMENTD-chiro-inositol

Treatment with D-chiro-inositol (capsule) for 3 months 600 mg/2 die

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Men aged between 50 and 75 * Affected by functional hypogonadism associated with male aging

Exclusion criteria

* Elevated ferritin, PRL, and/or elevated CRP values; diagnosis of primary hypogonadism; diagnosis of organic hypogonadotropic hypogonadism or secondary to other ongoing acute or chronic pathologies; presence of other pituitary deficits. * Alcohol use and/or drug abuse, recent hormone treatment, smoking, systemic or endocrine diseases, infection of the male accessory glands, medical history of cryptorchidism or varicocele, and micro-orchidism.

Design outcomes

Primary

Measure	Time frame	Description
Testosterone levels	From enrollment to three months	Variation of serum testosterone levels

Contacts

CONTACTMaurizio Carrino, MD

maurizio.carrino@aocardarelli.it+39 081 7472474

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026