Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04615767
Status:
COMPLETED
Last Update Posted:
2021-08-02
First Post:
2020-10-29
Brief Title:
D-chiro-inositol Increases Androgens and Reduces Estrogens in Human Serum
Sponsor:
AGUNCO Obstetrics and Gynecology Centre
Organization:
AGUNCO Obstetrics and Gynecology Centre
Study Overview
Official Title:
D-chiro-inositol a Putative Aromatase Inhibitor Increases Androgen and Reduces Estrogen Levels in Serum of Male Volunteers A Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-01
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:
The aim of this pilot study is to test the effect of a 30 day-D-chiro-inositol oral treatment on a set of clinical parameters mainly sex hormones in a group of male volunteers selected by their age and BMI to investigate if D-chiro-inositol acts as an aromatase inhibitor
Detailed Description:
This is an open label clinical trial with a dietary supplement carried out in male volunteers selected by their age and BMI The aim is to test the effect of oral daily treatment with 1 g D-chiro-inositol for 30 days on some clinical parameters to see if D-chiro-inositol acts as an aromatase inhibitor Testosterone estradiol TestosteroneEstradiol ratio Dehydroepiandrosterone sulfate Estrone glycemia and insulinemia with calculation of HOMA index follicle-stimulating hormone Luteinizing hormone D-chiro-inositol and Myo-inositol serum concentrations have to be determined before and after D-chiro-inositol administration
We wish to evaluate if this treatment for one month is able to change the sexual hormone levels increasing androgens and decreasing estrogens Furthermore we wish to control the safety profile of D-chiro-inositol a well-known molecule different from the classic aromatase inhibitors We think that our pilot study can open up new perspectives of research and therapeutic applications for this many-sided molecule
We wish to evaluate if this treatment for one month is able to change the sexual hormone levels increasing androgens and decreasing estrogens Furthermore we wish to control the safety profile of D-chiro-inositol a well-known molecule different from the classic aromatase inhibitors We think that our pilot study can open up new perspectives of research and therapeutic applications for this many-sided molecule
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