NCT07584772

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 7, 2026

Last Update Submit

May 7, 2026

Conditions

Functional Hypogonadism

Outcome Measures

Primary Outcomes (1)

  • Testosterone levels

    Variation of serum testosterone levels

    From enrollment to three months

Study Arms (1)

Treated

EXPERIMENTAL

Treatment with D-chiro-inositol

Dietary Supplement: D-chiro-inositol

Interventions

D-chiro-inositolDIETARY_SUPPLEMENT

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

Treated

Eligibility Criteria

Age50 Years - 75 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Maurizio Carrino, MD

CONTACT

+39 081 7472474maurizio.carrino@aocardarelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 13, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share