An interventional study of Myo-inositol + folic a. + α-lactalbumin and Myo-inositol + folic a. in PCOS and Myo-inositol-resistance, sponsored by Lo.Li.Pharma s.r.l. Completed at 1 site in Bulgaria. Open to female participants. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Lo.Li.Pharma s.r.l · Not applicable, Interventional, and Treatment
The investigator's aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients
In this study, the investigators expect about 30% of the PCOS patients enrolled to be resistant to Myo-inositol treatment for ovulation induction, probably due to the presence of malabsorption caused by gut dysbiosis. The most recent evidence proposes dysbiosis and related chronic low-grade inflammation as the new DOGMA behind PCOS pathogenesis. In this regard, the recent findings on alpha-lactalbumin reports its effect in improving the absorption of different nutrients including myo-inositol as well as a crucial factor for reducing inflammation. Furthermore, this whey protein is well known for its effect as trophic agent for gastrointestinal flora in infants. For all these reasons, the investigators expect that the treatment with Inofolic HP (Myo-inositol and alpha-lactalbumin) will get an efficacy 20-25% higher than the treatment with inofolic.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Lo.Li.Pharma s.r.l is the lead sponsor of 30 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: Myo-inositol + folic a.
Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin
3 months of treatment
Also known as: Inofolic HP
Drug page: Inositol
3 months of treatment
Also known as: Inofolic
ovulation induction
Ovulation indaction will by evaluated through ultrasound sonography
Time frame: after three months of treatment
Plan to share: Undecided
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Inositol