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Search / Trial NCT03667443

Myo-inositol Plus Alpha-lactalbumin in PCOS Myo-inositol-resistant Patients

Launched by LO.LI.PHARMA S.R.L · Sep 11, 2018

Trial Information

Current as of October 26, 2025

Completed

Keywords

Myo Inositol Alpha Lactalbumin Polycystic Ovary Syndrome Anovulation Infertility

ClinConnect Summary

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...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • POCS women diagnosed using the Rotterdam Criteria
  • Exclusion Criteria:
  • Amenorrhea (3 months)
  • Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
  • Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
  • Drastic changes in diet
  • Treatment with product containing Myo-inositol in the previous 3 months

About Lo.Li.Pharma S.R.L

lo.li.pharma s.r.l. is a leading pharmaceutical company dedicated to the development and commercialization of innovative therapies aimed at improving patient outcomes across various therapeutic areas. With a strong commitment to research and development, lo.li.pharma s.r.l. leverages cutting-edge science and technology to advance clinical trials that address unmet medical needs. The company prides itself on its rigorous quality standards and collaborative approach, working closely with healthcare professionals, regulatory bodies, and research institutions to bring safe and effective treatments to market. Through its strategic initiatives, lo.li.pharma s.r.l. strives to enhance the well-being of patients worldwide while fostering sustainable growth in the pharmaceutical industry.

Locations

Sofia, Bulgaria

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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