Use of D-Chiro-inositol in Male Functional Hypogonadism Associated With Sexual Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-chiro-inositol.
- Who it may be relevant to
- Registry conditions: Functional Hypogonadism. Basic parameters: 50 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 supplement D-chiro-inositol
Treatment with D-chiro-inositol (capsule) for 3 months 600 mg/2 die
Primary outcome measures
- Testosterone levels [Time frame: From enrollment to three months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07584772 · 07/26