Polycystic Ovarian Syndrome (PCOS)NCT06715527
Treatment of Women With Hyperandrogenic PCOS With Two Different Ratios of Myo-inositol:D-chiro-inositol: A Comparison
A study testing Myo-Inositol and D-Chiro-Inositol (40:1) and Myo-Inositol and D-Chiro-Inositol (3.6:1) in people with Polycystic Ovarian Syndrome (PCOS), run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- Myo-Inositol and D-Chiro-Inositol (40:1) and Myo-Inositol and D-Chiro-Inositol (3.6:1)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to 14 Mar 2025
- 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
- PCOS according to the Rotterdam Criteria
- Clinical or biochemical hyperandrogenism
Who cannot join
- other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism)
- other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome)
- use of medications that influence ovulation
- hormonal treatments
- chronic pharmacological therapies
- use of inositol-containing supplements
- regular consumption of inositol-enriched food
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome
In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study.
Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated.
In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Being tested
- Myo-Inositol and D-Chiro-Inositol (40:1), Myo-Inositol and D-Chiro-Inositol (3.6:1)
- Keywords
- PCOS, myo-inositol, D-chiro-inositol, menstual cycle
- 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-Inositol and D-Chiro-Inositol (40:1)Dietary supplement
Also called 40:1
Myo-inositol and D-chiro-inositol (40:1 ratio), 2 grams (twice a day) for three months
Myo-Inositol and D-Chiro-Inositol (3.6:1)Dietary supplement
Also called 3.6:1
Myo-inositol and D-chiro-inositol (3.6:1 ratio), 1.4 grams (once daily) for three months
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 40:1 ratio Receives: Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (40:1) |
| Comparator | Active comparator | Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 3.6:1 ratio Receives: Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (3.6:1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of regular menstrual cycle
Number (%) of patients with regular menstrual cycle at the end of the study
Measured: From enrollment (T0) to the completion of the study at 3 months (T3M)
Secondary outcomes (1)
Hormonal status
Changes of serum hormonal levels (Progesterone; FSH; LH; Estradiol; Testosterone; Insulin)
Measured: From enrollment (T0) to the completion of the study at 3 months (T3M)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Nov 2024
- Primary completion6 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06715527
- Sponsor's protocol ID
- Ino-ratio_2024
- Status last verified
- Apr 2025
- First submitted
- 28 Nov 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06715527
- Acronym / sponsor ID
- Ino-ratio_2024
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- PCOS, myo-inositol, D-chiro-inositol, menstual cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 4 Dec 2024 (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.
In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study.
Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated.
In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (40:1)Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 40:1 ratio |
| Comparator | Active comparator | Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (3.6:1)Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 3.6:1 ratio |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PCOS according to the Rotterdam Criteria
- Clinical or biochemical hyperandrogenism
Key exclusion criteria (7 listed)
- other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism)
- other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome)
- use of medications that influence ovulation
- hormonal treatments
- chronic pharmacological therapies
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-Inositol and D-Chiro-Inositol (40:1)Also: 40:1Myo-inositol and D-chiro-inositol (40:1 ratio), 2 grams (twice a day) for three months | Dietary supplement | Treatment |
| Myo-Inositol and D-Chiro-Inositol (3.6:1)Also: 3.6:1Myo-inositol and D-chiro-inositol (3.6:1 ratio), 1.4 grams (once daily) for three months | Dietary supplement | Comparator |
Primary outcome
Restoration of regular menstrual cycle
Time frame: From enrollment (T0) to the completion of the study at 3 months (T3M)
Number (%) of patients with regular menstrual cycle at the end of the study
1 secondary outcome
Hormonal status
Time frame: From enrollment (T0) to the completion of the study at 3 months (T3M)
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 8 Apr 2025.
- 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 and D-Chiro-Inositol (40:1) and Myo-Inositol and D-Chiro-Inositol (3.6:1) in people with Polycystic Ovarian Syndrome (PCOS), 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 2 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 8 Apr 2025. 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?
Restoration of regular menstrual cycle (time frame: From enrollment (T0) to the completion of the study at 3 months (T3M)). 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 8 Apr 2025.