Functional HypogonadismHERO_2025NCT07584772
Use of D-Chiro-inositol in Male Functional Hypogonadism Associated With Sexual Dysfunction
A study testing D-chiro-inositol in people with Functional Hypogonadism, run by Cardarelli Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Functional Hypogonadism
- What is being tested?
- D-chiro-inositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged between 50 and 75
- Affected by functional hypogonadism associated with male aging
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Functional Hypogonadism
- Being tested
- D-chiro-inositol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-chiro-inositolDietary supplement
Treatment with D-chiro-inositol (capsule) for 3 months 600 mg/2 die
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | Treatment with D-chiro-inositol Receives: Dietary Supplement: D-chiro-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone levels
Variation of serum testosterone levels
Measured: From enrollment to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardarelli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Carrino, Cardarelli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584772
- Sponsor's protocol ID
- 07/26
- Acronym
- HERO_2025
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of D-Chiro-inositol in Male Functional Hypogonadism Associated With Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT07584772
- Acronym / sponsor ID
- HERO_2025 / 07/26
- Conditions
- Functional Hypogonadism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cardarelli HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Dietary Supplement: D-chiro-inositolTreatment with D-chiro-inositol |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men aged between 50 and 75
- Affected by functional hypogonadism associated with male aging
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-chiro-inositolTreatment with D-chiro-inositol (capsule) for 3 months 600 mg/2 die | Dietary supplement | Treated |
Primary outcome
Testosterone levels
Time frame: From enrollment to three months
Variation of serum testosterone levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing D-chiro-inositol in people with Functional Hypogonadism, run by Cardarelli Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maurizio Carrino, MD (+39 081 7472474, maurizio.carrino@aocardarelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone levels (time frame: From enrollment to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.