Endometrial DiseasesNCT05283642
D-chiro-inositol and Endometrial Thickness
A study testing DCI in people with Endometrial Diseases, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
Investigation of the effects of D-chiro-inositol supplementation in women with altered endometrial thickness. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Endometrial Diseases
- What is being tested?
- DCI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2022to 20 Dec 2022
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- altered endometrial thickness
Who cannot join
- patients with cancer
- patients under hormonal treatments (progestogens and/or estrogens)
- patients supplemented with inositols
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of D-chiro-inositol in Endometrial Thickness
Investigation of the effects of D-chiro-inositol supplementation in women with altered endometrial thickness.
- Conditions
- Endometrial Diseases
- Being tested
- DCI
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCIDietary supplement
Oral supplementation with D-chiro-inositol once daily
| Study group | Role | What they receive |
|---|---|---|
| DCI | Experimental | Oral supplementation with D-chiro-inositol once a day Receives: Dietary Supplement: DCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endometrial thickness
Change in endometrial thickness by ultrasound measurement from baseline to three months
Measured: Two time points: baseline and after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start8 Mar 2022
- Primary completion29 Oct 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial DiseasesStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT05283642
- Sponsor's protocol ID
- DCI_GYN22
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of D-chiro-inositol in Endometrial Thickness
- ClinicalTrials.gov ID
- NCT05283642
- Acronym / sponsor ID
- DCI_GYN22
- Conditions
- Endometrial Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 29 Oct 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 17 Mar 2022 (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.
Investigation of the effects of D-chiro-inositol supplementation in women with altered endometrial thickness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCI | Experimental | Dietary Supplement: DCIOral supplementation with D-chiro-inositol once a day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- altered endometrial thickness
Key exclusion criteria (3 listed)
- patients with cancer
- patients under hormonal treatments (progestogens and/or estrogens)
- patients supplemented with inositols
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 |
|---|---|---|
| DCIOral supplementation with D-chiro-inositol once daily | Dietary supplement | DCI |
Primary outcome
Change in endometrial thickness
Time frame: Two time points: baseline and after three months
Change in endometrial thickness by ultrasound measurement from baseline to three months
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 23 Dec 2022.
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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 DCI in people with Endometrial Diseases, 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 1 inclusion and 3 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 23 Dec 2022. 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 in endometrial thickness (time frame: Two time points: baseline and after 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 23 Dec 2022.