Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03422289
Status:
COMPLETED
Last Update Posted:
2018-02-06
First Post:
2018-01-10
Brief Title:
Improved Effects of MI Plus Alpha-LA in PCOS
Sponsor:
LoLiPharma srl
Organization:
LoLiPharma srl
Study Overview
Official Title:
Improved Effects of Myo-inositol in Association With Alpha-lactalbumin in PCOS Women
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PCOS patients are initially treated with 2 g myo-inositol and 02 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 02 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
Detailed Description:
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 02 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 02 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
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 02 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 02 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
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?:
None
Is an FDA AA801 Violation?:
None