An interventional study of myo-inositol plus folic acid and myo-inositol plus folic acid plus alpha-lactalbumin in Polycystic Ovary Syndrome, sponsored by Lo.Li.Pharma s.r.l. Completed at 1 site in Italy. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by Lo.Li.Pharma s.r.l · Not applicable, Interventional, and Treatment
PCOS patients are initially treated with 2 g myo-inositol and 0.2 mg folic acid, two times per day by oral route, for three months. Among them, the subjects who have not ovulated despite this treatment are administered with 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. Most of them improve and achieve ovulation. Therefore, the combination of α-lactalbumin with myo-inositol allows to get a significant result in the treatment of PCOS patients.
Polycystic ovary syndrome is a complex chronic condition inducing several related disorders, such as subfertility and pregnancy complications. So far myo-inositol, successfully used in PCOS, has not been always effective in all patients. Aiming at overcoming this drawback, we tested a new formulation with myo-inositol and α-lactalbumin, in consideration of the effects exerted by α-lactalbumin in favoring molecule passage among body compartments, and also in consideration of its anti-inflammatory activity.
Only PCOS patients, according to Rotterdam ESHRE-ASRM criteria, with anovulation and infertility > 1 year, were included in the study. Following a treatment with 2 g myo-inositol and 0.2 mg folic acid, a part of them are resistant and do not ovulate.
These non-responders to myo-inositol alone undergo the second phase of the study, receiving 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. After this combined treatment, the majority of them ovulate, showing a hormone and lipid profile improvement. In addition, myo-inositol plasma levels at the end of the treatment are significantly higher than at baseline and comparable to those patients who respond positively to myo-inositol alone.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 37 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
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Exclusion Criteria:
2 g myo-inositol and 0.2 mg folic acid orally twice a day for three months, in order to induce ovulation.
Dietary Supplement: myo-inositol plus folic acid
2 g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin, twice a day for three months in order to test if α-lactalbumin addition allows to induce ovulation
Dietary Supplement: myo-inositol plus folic acid plus alpha-lactalbumin
Drug pages: Inositol · Folic Acid
this treatment is made in the first phase of the study for three months
Drug pages: Inositol · Folic Acid · Lactalbumin
this treatment is made in the second phase of the study and it has a new molecule added to the previous ones administered in the first phase of the study
Restoration of ovulation
Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle.
Time frame: after three months of treatment
Increase of myo-inositol plasma levels after the treatment with myo-inositol plus alpha-lactalbumin compared to the levels at the baseline
Myo-inositol was dosed in plasma by means of gas chromatography-mass spectrometry
Time frame: after three months of treatment
Plan to share: No
Ran from Nov 2016 to primary completion in Oct 2017, 11 months.
Of 217 interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's 11 months is below that.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Inositol · Folic Acid · Lactalbumin