PCOSPhase 4NCT01626443
Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions
A Phase 4 study testing Myo-inositol + D-chiro-inositol + Folic acid and Folic acid in people with PCOS, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is characterized by menstrual abnormalities, clinical or biochemical hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Read more about this study
- Who is it for?
- Ages 14 to 40 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Myo-inositol + D-chiro-inositol + Folic acid and Folic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jun 2015
- Phase
- Phase 4
- 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 14 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- PCOS
- Women aged between 14-40 years
- BMI > 28
- Hyperinsulinemia
Who cannot join
- Pre-existing secondary endocrine and metabolic disorders
- Pre-existing secondary adrenal disorders
- Pharmacologic treatment in the last 3 months before entering the study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is characterized by menstrual abnormalities, clinical or biochemical hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of developing several metabolic disorders. Inositol is a six-carbon polyol which has been characterized as an insulin sensitizer: it exists as nine different isomers and among them myo-inositol and D-chiroinositol are the most represented and studied in physiology and physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels.
The aim of this randomized study is to evaluate the metabolic and ovaric effects of a six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and hyperinsulemia.
- Conditions
- PCOS
- Being tested
- Myo-inositol + D-chiro-inositol + Folic acid, Folic acid
- Keywords
- PCOS, Metabolic disorders, Ovarian functionality, Myo-inositol, D-chiro-inositol
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositol + D-chiro-inositol + Folic acidDietary supplement
Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die
Folic acidDietary supplement
Folic acid (200 mcg); 2 x die
| Study group | Role | What they receive |
|---|---|---|
| Folic acid | Active comparator | Not described Receives: Dietary Supplement: Folic acid |
| Inofolic Combi | Experimental | Not described Receives: Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual cycle restoration
Measured: At 6 months
Score hirsutism (Ferriman-Gallwey classification)
Measured: At 6 months
Serum progesterone
Measured: At 6 months
Testosterone level test
Measured: At 6 months
Oral glucose tolerance test (OGTT)
Evaluation of glycemia and insulinemia levels
Measured: At 6 months
Homeostasis Model Assessment (HOMA-index)
Measured: At 6 months
Sex hormone binding globulin (SHBG) test
Measured: At 6 months
Androstenediol level test
Measured: At 6 months
Androstenedione level test
Measured: At 6 months
Free Androgen Index (FAI) level test
Measured: At 6 months
Secondary outcomes (7)
Body Mass Index (BMI)
Measured: At 6 months
Change from baseline in diastolic blood pressure levels
Measured: At 6 months
Change from baseline in systolic blood pressure levels
Measured: At 6 months
Number of patients with abnormal ovarian size and morphology
Ovarian ultrasound scan for the assessment of size and morphology
Measured: At 6 months
Luteinizing Hormone (LH) level test
Analysis of LH levels should be performed between the 7th and the 10th day of the cycle
Measured: At 6 months
Follicle Stimulating Hormone (FSH) level test
Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle
Measured: At 6 months
Estradiol (E2) level test
Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 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
- NCT01626443
- Sponsor's protocol ID
- MI-DCI
- Status last verified
- Feb 2017
- First submitted
- 15 Jun 2012
- Last updated
- 14 Feb 2017
- Results posted
- No
Publications
Diamanti-Kandarakis E, Kouli CR, Bergiele AT, Filandra FA, Tsianateli TC, Spina GG, Zapanti ED, Bartzis MI. A survey of the polycystic ovary syndrome in the Greek island of Lesbos: hormonal and metabolic profile. J Clin Endocrinol Metab. 1999 Nov;84(11):4006-11. doi: 10.1210/jcem.84.11.6148.
PubMed 10566641Nestler JE. Role of hyperinsulinemia in the pathogenesis of the polycystic ovary syndrome, and its clinical implications. Semin Reprod Endocrinol. 1997 May;15(2):111-22. doi: 10.1055/s-2007-1016294.
PubMed 9165656Baillargeon JP, Nestler JE, Ostlund RE, Apridonidze T, Diamanti-Kandarakis E. Greek hyperinsulinemic women, with or without polycystic ovary syndrome, display altered inositols metabolism. Hum Reprod. 2008 Jun;23(6):1439-46. doi: 10.1093/humrep/den097. Epub 2008 Mar 29.
PubMed 18375940Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.
PubMed 10219066Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6. doi: 10.1093/humrep/17.6.1591.
PubMed 12042283Vermeulen A, Verdonck L, Kaufman JM. A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab. 1999 Oct;84(10):3666-72. doi: 10.1210/jcem.84.10.6079.
PubMed 10523012Legro RS, Castracane VD, Kauffman RP. Detecting insulin resistance in polycystic ovary syndrome: purposes and pitfalls. Obstet Gynecol Surv. 2004 Feb;59(2):141-54. doi: 10.1097/01.OGX.0000109523.25076.E2.
PubMed 14752302
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions
- ClinicalTrials.gov ID
- NCT01626443
- Acronym / sponsor ID
- MI-DCI
- Conditions
- PCOS
- Keywords
- PCOS, Metabolic disorders, Ovarian functionality, Myo-inositol, D-chiro-inositol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Jun 2012 (estimated)
- 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.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is characterized by menstrual abnormalities, clinical or biochemical hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of developing several metabolic disorders. Inositol is a six-carbon polyol which has been characterized as an insulin sensitizer: it exists as nine different isomers and among them myo-inositol and D-chiroinositol are the most represented and studied in physiology and physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels.
The aim of this randomized study is to evaluate the metabolic and ovaric effects of a six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and hyperinsulemia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic acid | Active comparator | Dietary Supplement: Folic acid |
| Inofolic Combi | Experimental | Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- PCOS
- Women aged between 14-40 years
- BMI > 28
- Hyperinsulinemia
Key exclusion criteria (4 listed)
- Pre-existing secondary endocrine and metabolic disorders
- Pre-existing secondary adrenal disorders
- Pharmacologic treatment in the last 3 months before entering the study
- Pregnancy
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 + D-chiro-inositol + Folic acidMyo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die | Dietary supplement | Inofolic Combi |
| Folic acidFolic acid (200 mcg); 2 x die | Dietary supplement | Folic acid |
Primary outcome
Menstrual cycle restoration
Time frame: At 6 months
Score hirsutism (Ferriman-Gallwey classification)
Time frame: At 6 months
Serum progesterone
Time frame: At 6 months
Testosterone level test
Time frame: At 6 months
Oral glucose tolerance test (OGTT)
Time frame: At 6 months
Evaluation of glycemia and insulinemia levels
Homeostasis Model Assessment (HOMA-index)
Time frame: At 6 months
Sex hormone binding globulin (SHBG) test
Time frame: At 6 months
Androstenediol level test
Time frame: At 6 months
Androstenedione level test
Time frame: At 6 months
Free Androgen Index (FAI) level test
Time frame: At 6 months
7 secondary outcomes
Body Mass Index (BMI)
Time frame: At 6 months
Change from baseline in diastolic blood pressure levels
Time frame: At 6 months
Change from baseline in systolic blood pressure levels
Time frame: At 6 months
Number of patients with abnormal ovarian size and morphology
Time frame: At 6 months
Luteinizing Hormone (LH) level test
Time frame: At 6 months
Follicle Stimulating Hormone (FSH) level test
Time frame: At 6 months
Estradiol (E2) level test
Time frame: At 6 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 14 Feb 2017.
- Background: PubMed 10566641Diamanti-Kandarakis E, Kouli CR, Bergiele AT, Filandra FA, Tsianateli TC, Spina GG, Zapanti ED, Bartzis MI. A survey of the polycystic ovary syndrome in the Greek island of Lesbos: hormonal and metabolic profile. J Clin Endocrinol Metab. 1999 Nov;84(11):4006-11. doi: 10.1210/jcem.84.11.6148.
- Background: PubMed 9165656Nestler JE. Role of hyperinsulinemia in the pathogenesis of the polycystic ovary syndrome, and its clinical implications. Semin Reprod Endocrinol. 1997 May;15(2):111-22. doi: 10.1055/s-2007-1016294.
- Background: PubMed 18375940Baillargeon JP, Nestler JE, Ostlund RE, Apridonidze T, Diamanti-Kandarakis E. Greek hyperinsulinemic women, with or without polycystic ovary syndrome, display altered inositols metabolism. Hum Reprod. 2008 Jun;23(6):1439-46. doi: 10.1093/humrep/den097. Epub 2008 Mar 29.
- Background: PubMed 10219066Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.
- Background: PubMed 12042283Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6. doi: 10.1093/humrep/17.6.1591.
- Background: PubMed 10523012Vermeulen A, Verdonck L, Kaufman JM. A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab. 1999 Oct;84(10):3666-72. doi: 10.1210/jcem.84.10.6079.
- Background: PubMed 14752302Legro RS, Castracane VD, Kauffman RP. Detecting insulin resistance in polycystic ovary syndrome: purposes and pitfalls. Obstet Gynecol Surv. 2004 Feb;59(2):141-54. doi: 10.1097/01.OGX.0000109523.25076.E2.
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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 Phase 4 study testing Myo-inositol + D-chiro-inositol + Folic acid and Folic acid in people with 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 4 inclusion and 4 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 14 Feb 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Menstrual cycle restoration (time frame: At 6 months). The study lists 10 primary outcomes in all. 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 NCT01626443, which also lists 7 linked publications.
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 14 Feb 2017.