Ignite Creation Date:
2024-05-05 @ 9:33 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00916396
Status:
UNKNOWN
Last Update Posted:
2009-12-01
First Post:
2009-06-07
Brief Title:
Dehydroepiandrosterone DHEA Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Dehydroepiandrosterone DHEA Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder Modulation of Sexual Libido by Androgens and Neurosteroids
Status:
UNKNOWN
Status Verified Date:
2009-11
Last Known Status:
RECRUITING
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:
Hypoactive Sexual Desire Disorder HSDD is a common syndrome characterized by low sexual desire causing marked distress The involvement of DHEA in sexual function is unknown however DHEA treatment increased desire in depressed subjects In the current research we will treat 45 women and men suffering from low sexual desire with DHEA or placebo for 6 weeks The studys primary goal is to determine the effect of DHEA treatment on sexual desire and to find if there is a connection between levels of hormones and change in desire Outcome measures will include hormonal levels and psychological state Our secondary goal is to compare baseline hormones measures in individuals with low sexual desire to normal controls For that purpose we will measure the hormonal baseline levels among 20 normal subjects
Detailed Description:
Hypoactive Sexual Desire Disorder HSDD is a very common syndrome in adult women and men characterized by a severe deficiency in the desire for sexual activity causing marked distress There is some data that androgens such as testosterone have some beneficial effect in this condition DHEA is a neurosteroid that is metabolized into testosterone and estrogen both of assumed importance in the regulation of sexual libido The direct involvement of DHEA in the regulation of sexual function is unknown however DHEA treatment improved libido in midlife-onset depressed subjects In this study we will treat women and men suffering from HSDD with DHEA The studys first objective is to determine the effect of DHEA treatment on sexual libido in menopausal women and both young and mid-aged men The secondary objective is to compare baseline measures of DHEA androgens and other neurosteroids in individuals with HSDD to controls Furthermore we will investigate possible correlations between plasma and urine levels of several neurosteroids and change in measures of libido Fifty women and men diagnosed with HSDD will be treated with either 100 mg of DHEA or placebo for 6 weeks in a double-blind placebo-controlled study Outcome measures will include several 17-Ketosteroids DHEAS and bioavailable testosterone Psychological outcome measures will include sexual function mood and well-being Twenty controls without HSDD will also be recruited to determine and compare their baseline levels of neurosteroids
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None