Polycystic Ovary SyndromeNCT05678114
Inositol Treatment in Different Type of PCOS Phenotype
A study testing Myo-inositol in people with Polycystic Ovary Syndrome, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria) Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Myo-inositol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 21 Dec 2022to 12 May 2023
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with PCOS of any phenotype
Who cannot join
- hormonal treatment (such as contraceptive pill)
- use of supplements containing myo-inositol
- severe co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Inositol Treatment in Women With PCOS of Different Phenotype
Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria)
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Myo-inositol
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDietary supplement
Myo-inositol (4g/die)
| Study group | Role | What they receive |
|---|---|---|
| Hyperandrogenic PCOS | Experimental | Not described Receives: Dietary Supplement: Myo-inositol |
| Non-hyperandrogenic PCOS | Experimental | Not described Receives: Dietary Supplement: Myo-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regularization of the menstrual cycle
Number of women with regular/altered menstrual cycle
Measured: Change from baseline number of women with irregular menstrual cycle at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start21 Dec 2022
- Primary completion28 Apr 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT05678114
- Sponsor's protocol ID
- Ins-PCOSphenotype
- Status last verified
- May 2023
- First submitted
- 21 Dec 2022
- Last updated
- 16 May 2023
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inositol Treatment in Women With PCOS of Different Phenotype
- ClinicalTrials.gov ID
- NCT05678114
- Acronym / sponsor ID
- Ins-PCOSphenotype
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 10 Jan 2023 (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.
Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperandrogenic PCOS | Experimental | Dietary Supplement: Myo-inositol |
| Non-hyperandrogenic PCOS | Experimental | Dietary Supplement: Myo-inositol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with PCOS of any phenotype
Key exclusion criteria (3 listed)
- hormonal treatment (such as contraceptive pill)
- use of supplements containing myo-inositol
- severe co-morbidities
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 |
|---|---|---|
| Myo-inositolMyo-inositol (4g/die) | Dietary supplement | Hyperandrogenic PCOS, Non-hyperandrogenic PCOS |
Primary outcome
Regularization of the menstrual cycle
Time frame: Change from baseline number of women with irregular menstrual cycle at 4 months
Number of women with regular/altered menstrual cycle
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 16 May 2023.
- 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 Myo-inositol in people with Polycystic Ovary Syndrome, 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 16 May 2023. 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?
Regularization of the menstrual cycle (time frame: Change from baseline number of women with irregular menstrual cycle at 4 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 16 May 2023.