Male HypogonadismNCT04708249
D-chiroinositol Administration in Hypogonadal Males
A study testing D-chiroinositol in people with Male Hypogonadism and Sexual Dysfunction, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. Read more about this study
- Who is it for?
- Ages 65 to 75 years, men only
- Conditions the study is for
- Male Hypogonadism, Sexual Dysfunction
- What is being tested?
- D-chiroinositol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jan 2021to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 75 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Men, with a diagnosis of Late-Onset Male Hypogonadism
- Insulin resistance (HOMA Index > 2,5)
- BMI between 25 and 30
Who cannot join
- Alcohol intake and/or drug abuse
- Recent hormonal treatment
- Smoking
- Obesity
- Systemic or endocrine diseases
- Male accessory gland infection
- Clinical history of cryptorchidism or varicocele and micro-orchidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males
D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In this regard, DCI administration in case of reduced levels of testosterone, could be a good therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH) in undoubtedly an interesting target. LOH is a reduction of testosterone level due to advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately, there is a lack of information about TRT safety, especially in older men. For these reasons, the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation in LOH patient.
- Conditions
- Male Hypogonadism, Sexual Dysfunction
- Being tested
- D-chiroinositol
- Keywords
- Male Hypogonadism, Testosterone, Aromatase, D-chiroinositol, Sexual dysfunction
- Medical subject headings
- Eunuchism, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-chiroinositolDietary supplement
Supplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| D-chiroinositol treatment | Experimental | Not described Receives: Dietary Supplement: D-chiroinositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Serum Testosterone at 1 month
Level of testosterone detected in the blood in ng/dL
Measured: At baseline and after 30 days of treatment
Secondary outcomes (12)
Change from Baseline Weight at 1 month
Body weight of patients reported in kg
Measured: At baseline and after 30 days of treatment
Change from Baseline Waist circumference at 1 month
Waist circumference of patients reported in cm
Measured: At baseline and after 30 days of treatment
Change from Baseline BMI at 1 month
Body Mass Index of patients calculated as kg/m2, where kg is the weight measured for eah patient while m2 is his height squared
Measured: At baseline and after 30 days of treatment
Change from Baseline Insulin at 1 month
Level of fasting insulin detected in the blood and reported in microU/L
Measured: At baseline and after 30 days of treatment
Change from Baseline Glycaemia at 1 month
Level of fasting glycaemia detected in the blood and reported in mg/dL
Measured: At baseline and after 30 days of treatment
Change from Baseline HOMA index at 1 month
HOMA index known as Homeostatic Model Assessment for Insulin Resistance is: (fasting glycaemia x fasting insulin)/405
Measured: At baseline and after 30 days of treatment
Change from Baseline Androstenedione at 1 month
Level of androstenedione detected in the blood and reported in ng/mL
Measured: At baseline and after 30 days of treatment
Change from Baseline Luteinizing Hormone at 1 month
Level of luteinizing hormone detected in the blood and reported in mUI/ml
Measured: At baseline and after 30 days of treatment
Change from Baseline Oestradiol at 1 month
Level of oestradiol detected in the blood and reported in pg/mL
Measured: At baseline and after 30 days of treatment
Change from Baseline Oestrone at 1 month
Level of oestrone detected in the blood and reported in pg/mL
Measured: At baseline and after 30 days of treatment
Change from Baseline Testosterone/Oestradiol ratio at 1 month
Ratio between the levels of oestradiol and testosterone detected in the blood
Measured: At baseline and after 30 days of treatment
Change from Baseline Strength Test at 1 month
Measurement of strength performed with the dominant hand using a hand-held dynamometer (Good Strength, IGS01, Metitur Oy, Jyväskylä, Finland) with the participant in the seated position with elbow flexed at 110°. The participant will be instructed to squeeze the handle as hard as possible for 3-5 seconds and the stregth will be recorded in kg
Measured: At baseline and after 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start18 Jan 2021
- Primary completion24 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708249
- Sponsor's protocol ID
- DCI_HYPOGONADAL_MALES
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nordio M, Kumanov P, Chiefari A, Puliani G. D-Chiro-Inositol improves testosterone levels in older hypogonadal men with low-normal testosterone: a pilot study. Basic Clin Androl. 2021 Nov 12;31(1):28. doi: 10.1186/s12610-021-00146-4.
PubMed 34763665
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males
- ClinicalTrials.gov ID
- NCT04708249
- Acronym / sponsor ID
- DCI_HYPOGONADAL_MALES
- Conditions
- Male Hypogonadism, Sexual Dysfunction
- Keywords
- Male Hypogonadism, Testosterone, Aromatase, D-chiroinositol, Sexual dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 Jan 2021 (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.
D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In this regard, DCI administration in case of reduced levels of testosterone, could be a good therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH) in undoubtedly an interesting target. LOH is a reduction of testosterone level due to advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately, there is a lack of information about TRT safety, especially in older men. For these reasons, the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation in LOH patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D-chiroinositol treatment | Experimental | Dietary Supplement: D-chiroinositol |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Men, with a diagnosis of Late-Onset Male Hypogonadism
- Insulin resistance (HOMA Index > 2,5)
- BMI between 25 and 30
Key exclusion criteria (7 listed)
- Alcohol intake and/or drug abuse
- Recent hormonal treatment
- Smoking
- Obesity
- Systemic or endocrine diseases
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-chiroinositolSupplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days. | Dietary supplement | D-chiroinositol treatment |
Primary outcome
Change from Baseline Serum Testosterone at 1 month
Time frame: At baseline and after 30 days of treatment
Level of testosterone detected in the blood in ng/dL
12 secondary outcomes
Change from Baseline Weight at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline Waist circumference at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline BMI at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline Insulin at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline Glycaemia at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline HOMA index at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline Androstenedione at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline Luteinizing Hormone at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline Oestradiol at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline Oestrone at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline Testosterone/Oestradiol ratio at 1 month
Time frame: At baseline and after 30 days of treatment
Change from Baseline Strength Test at 1 month
Time frame: At baseline and after 30 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Derived from this study: PubMed 34763665Nordio M, Kumanov P, Chiefari A, Puliani G. D-Chiro-Inositol improves testosterone levels in older hypogonadal men with low-normal testosterone: a pilot study. Basic Clin Androl. 2021 Nov 12;31(1):28. doi: 10.1186/s12610-021-00146-4.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-chiroinositol in people with Male Hypogonadism and Sexual Dysfunction, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Serum Testosterone at 1 month (time frame: At baseline and after 30 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04708249, which also lists 1 linked publication.
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 2 Mar 2021.