Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034021
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-04-19
Brief Title:
Ginkgo Biloba Antidepressant-Induced Sexual Dysfunction
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Ginkgo Biloba Antidepressant-Induced Sexual Dysfunction
Status:
COMPLETED
Status Verified Date:
2006-07
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 purpose of this study is to provide the first empirical examination of the effects of Ginkgo biloba GBE sex therapy and a combination of the two on subjective and physiological measures of sexual function in women who are experiencing sexual disorders secondary to antidepressants
Detailed Description:
Virtually all antidepressant medications are associated with a high incidence of adverse sexual side effects In women the side effects most commonly reported include decreased sexual arousal with decreased lubrication delayed or inhibited orgasm and decreased sexual desire To date there are no effective pharmacological antidotes for treating these sexual side effects Ginkgo biloba extract GBE a naturally occurring substance from the ancient Chinese Ginkgo tree has properties proven to increase peripheral blood flow and to facilitate the relaxation of smooth muscle tissue Its effectiveness in this regard has been demonstrated in numerous clinical trials that show gingko biloba to be highly efficient in treating peripheral vascular disorders Female sexual arousal involves a complex interplay of these very actions - the relaxation of smooth muscle tissue and the inflow of blood to the genital region Hence pharmacologically it is feasible that GBE may be effective in enhancing female sexual arousal Moreover given that the mechanisms hypothesized to facilitate female sexual function are operative at a peripheral rather than a central ie neurotransmitter level it is unlikely that GBE would adversely impact the mood-alleviating therapeutic effects of antidepressant medications that are believed to be centrally mediated Limited uncontrolled studies lend support to this hypothesis The purpose of the present study is to provide the first empirical examination of the effects of both acute and chronic GBE on subjective and physiological measures of sexual function in women who are experiencing clinically diagnosable hypoactive sexual desire disorder female sexual arousal disorder andor inhibited female orgasm secondary to either to fluoxetine sertraline or paroxetine use Women N 110 stabilized on antidepressant medication and free of a current Axis I disorder will be randomized to 8 weeks of daily treatment with either GBE 200 mg or placebo Sexual functioning will be assessed through a daily patient diary recordings b patient-rating scales completed each week and c blind independent evaluator ratings The acute effects of GBE will also be assessed using vaginal photoplethysmograph techniques to assess genital blood flow both prior to and following chronic GBE treatment The findings from the present study will a help determine whether chronic andor acute GBE facilitates sexual function in women with antidepressant-induced sexual dysfunction and b examine whether acute GBE influences vaginal measures of sexual arousal If effective GBE could play a significant adjunctive role in the treatment of clinical depression and other psychological disorders commonly treated with antidepressant medications
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