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NCT Number: NCT07584772

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

D-chiro-inositol

Dietary Supplement

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

Primary outcomes

  1. Testosterone levels

    Time frame: From enrollment to three months

    Variation of serum testosterone levels

Study contacts

Contact information is provided by the study sponsor or research team.

Maurizio Carrino, MD

CONTACT

[email protected]

+39 081 7472474

Sponsors and collaborators

Lead sponsor

Cardarelli Hospital

Other

Registry information

Acronym: HERO_2025

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 13, 2026

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.

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