Low Serum Testosterone Levels in ManNCT04615767
D-chiro-inositol Increases Androgens and Reduces Estrogens in Human Serum
A study testing D-chiro-inositol in people with Low Serum Testosterone Levels in Man, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
The aim of this pilot study is to test the effect of a 30 day-D-chiro-inositol oral treatment on a set of clinical parameters (mainly sex hormones) in a group of male volunteers selected by their age and BMI to investigate if D-chiro-inositol acts as an aromatase inhibitor. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Serum Testosterone Levels in Man
- 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
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2020to 16 Dec 2020
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) range is between 22 and 34 kg/m2, in order to include subjects with normal weight, overweight and obese. Subjects with altered glycemia or hormonal status due to age or weight were enrolled in the study.
Who cannot join
- Men with poor general health were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D-chiro-inositol, a Putative Aromatase Inhibitor, Increases Androgen and Reduces Estrogen Levels in Serum of Male Volunteers. A Pilot Study.
The aim of this pilot study is to test the effect of a 30 day-D-chiro-inositol oral treatment on a set of clinical parameters (mainly sex hormones) in a group of male volunteers selected by their age and BMI to investigate if D-chiro-inositol acts as an aromatase inhibitor.
Read the detailed description
This is an open label clinical trial with a dietary supplement carried out in male volunteers selected by their age and BMI. The aim is to test the effect of oral daily treatment with 1 g D-chiro-inositol for 30 days on some clinical parameters, to see if D-chiro-inositol acts as an aromatase inhibitor. Testosterone, estradiol, Testosterone/Estradiol ratio, Dehydroepiandrosterone sulfate, Estrone, glycemia and insulinemia (with calculation of HOMA index), follicle-stimulating hormone, Luteinizing hormone, D-chiro-inositol and Myo-inositol serum concentrations have to be determined before and after D-chiro-inositol administration.
We wish to evaluate if this treatment for one month is able to change the sexual hormone levels, increasing androgens and decreasing estrogens. Furthermore, we wish to control the safety profile of D-chiro-inositol, a well-known molecule, different from the classic aromatase inhibitors. We think that our pilot study can open up new perspectives of research and therapeutic applications for this many-sided molecule.
- Conditions
- Low Serum Testosterone Levels in Man
- Being tested
- D-chiro-inositol
- Keywords
- Testosterone, DHEAS, Estradiol, Estrone, HOMA index, 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
as described previously
| Study group | Role | What they receive |
|---|---|---|
| D-chiro-inositol | Experimental | Volunteers are orally administered with 1 g D-chiro-inositol per day (two doses in capsules of 500 mg each, one in the morning and the other one in the evening) for thirty days Receives: Dietary Supplement: D-chiro-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the Testosterone/Estradiol ratio in serum
Assessment of the D-Chiro-Inositol treatment to increase the Testosterone/Estradiol ratio by detecting these physiological parameters in serum
Measured: Thirty days
Secondary outcomes (3)
Dehydroepiandrosterone sulfate
Detecting the serum levels of Dehydroepiandrosterone sulfate
Measured: Thirty days
Estrone
Detecting the serum levels of Estrone
Measured: Thirty days
Homeostatic Model Assessment for Insulin Resistance (HOMA) Index
Detecting glycemia and insulinemia
Measured: Thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start28 Oct 2020
- Primary completion6 Dec 2020
- Study completion16 Dec 2020
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 Low Serum Testosterone Levels in ManStudies 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
- Model description
- Ten male volunteers are treated daily with 1 g D-chiro-inositol for 30 days (2 capsules containing 500 mg each, twice a day). The serum levels of the detected parameters at the end of treatment are compared to the values found in the volunteers at the baseline, used as controls. Parameters under analysis: Testosterone/Estradiol ratio, Testosterone, dehydroepiandrosterone, estradiol, estrone, glycemia and insulinemia with Homeostatic Model Assessment for Insulin Resistance (HOMA) index, follicle stimulating hormone, luteinizing hormone, D-chiro-inositol and myo-inositol.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Monastra, Principal investigator, Systems Biology Group Lab, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615767
- Sponsor's protocol ID
- UVittorio1
- Status last verified
- Jan 2021
- First submitted
- 29 Oct 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monastra G, Vazquez-Levin M, Bezerra Espinola MS, Bilotta G, Lagana AS, Unfer V. D-chiro-inositol, an aromatase down-modulator, increases androgens and reduces estrogens in male volunteers: a pilot study. Basic Clin Androl. 2021 Jun 3;31(1):13. doi: 10.1186/s12610-021-00131-x.
PubMed 34078260
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-chiro-inositol, a Putative Aromatase Inhibitor, Increases Androgen and Reduces Estrogen Levels in Serum of Male Volunteers. A Pilot Study.
- ClinicalTrials.gov ID
- NCT04615767
- Acronym / sponsor ID
- UVittorio1
- Conditions
- Low Serum Testosterone Levels in Man
- Keywords
- Testosterone, DHEAS, Estradiol, Estrone, HOMA index, D-chiro-inositol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 4 Nov 2020 (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.
The aim of this pilot study is to test the effect of a 30 day-D-chiro-inositol oral treatment on a set of clinical parameters (mainly sex hormones) in a group of male volunteers selected by their age and BMI to investigate if D-chiro-inositol acts as an aromatase inhibitor.
Detailed description
This is an open label clinical trial with a dietary supplement carried out in male volunteers selected by their age and BMI. The aim is to test the effect of oral daily treatment with 1 g D-chiro-inositol for 30 days on some clinical parameters, to see if D-chiro-inositol acts as an aromatase inhibitor. Testosterone, estradiol, Testosterone/Estradiol ratio, Dehydroepiandrosterone sulfate, Estrone, glycemia and insulinemia (with calculation of HOMA index), follicle-stimulating hormone, Luteinizing hormone, D-chiro-inositol and Myo-inositol serum concentrations have to be determined before and after D-chiro-inositol administration.
We wish to evaluate if this treatment for one month is able to change the sexual hormone levels, increasing androgens and decreasing estrogens. Furthermore, we wish to control the safety profile of D-chiro-inositol, a well-known molecule, different from the classic aromatase inhibitors. We think that our pilot study can open up new perspectives of research and therapeutic applications for this many-sided molecule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ten male volunteers are treated daily with 1 g D-chiro-inositol for 30 days (2 capsules containing 500 mg each, twice a day). The serum levels of the detected parameters at the end of treatment are compared to the values found in the volunteers at the baseline, used as controls. Parameters under analysis: Testosterone/Estradiol ratio, Testosterone, dehydroepiandrosterone, estradiol, estrone, glycemia and insulinemia with Homeostatic Model Assessment for Insulin Resistance (HOMA) index, follicle stimulating hormone, luteinizing hormone, D-chiro-inositol and myo-inositol.
| Arm | Type | Receives |
|---|---|---|
| D-chiro-inositol | Experimental | Dietary Supplement: D-chiro-inositolVolunteers are orally administered with 1 g D-chiro-inositol per day (two doses in capsules of 500 mg each, one in the morning and the other one in the evening) for thirty days |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) range is between 22 and 34 kg/m2, in order to include subjects with normal weight, overweight and obese. Subjects with altered glycemia or hormonal status due to age or weight were enrolled in the study.
Key exclusion criteria (1 listed)
- Men with poor general health were excluded from the study.
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-inositolas described previously | Dietary supplement | D-chiro-inositol |
Primary outcome
Improvement of the Testosterone/Estradiol ratio in serum
Time frame: Thirty days
Assessment of the D-Chiro-Inositol treatment to increase the Testosterone/Estradiol ratio by detecting these physiological parameters in serum
3 secondary outcomes
Dehydroepiandrosterone sulfate
Time frame: Thirty days
Estrone
Time frame: Thirty days
Homeostatic Model Assessment for Insulin Resistance (HOMA) Index
Time frame: Thirty days
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 Aug 2021.
- Derived from this study: PubMed 34078260Monastra G, Vazquez-Levin M, Bezerra Espinola MS, Bilotta G, Lagana AS, Unfer V. D-chiro-inositol, an aromatase down-modulator, increases androgens and reduces estrogens in male volunteers: a pilot study. Basic Clin Androl. 2021 Jun 3;31(1):13. doi: 10.1186/s12610-021-00131-x.
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.
Giovanni Monastra principal investigator
Systems Biology Group Lab, Rome, Italy
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-chiro-inositol in people with Low Serum Testosterone Levels in Man, run by AGUNCO Obstetrics and Gynecology Centre 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 1 inclusion and 1 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 Aug 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?
Improvement of the Testosterone/Estradiol ratio in serum (time frame: Thirty days). 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 NCT04615767, 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 Aug 2021.