Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03667443
Status:
WITHDRAWN
Last Update Posted:
2022-04-13
First Post:
2018-08-01
Brief Title:
Myo-inositol Plus Alpha-lactalbumin in PCOS Myo-inositol-resistant Patients
Sponsor:
LoLiPharma srl
Organization:
LoLiPharma srl
Study Overview
Official Title:
The Effects of Myo-inositol Plus Alpha-lactalbumin in Ovulation Induction of PCOS Myo-inositol-resistant Patients
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to COVID-19 restrictions enrollment was unsuccessful
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None