NCT00034021

Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 (i.e., 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, and/or 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 and/or 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.

Conditions

• Hypoactive Sexual Desire Disorder
• Sexual Dysfunctions, Psychological

Interventions

Type	Name	Description
DRUG	Ginkgo Biloba
BEHAVIORAL	Sex Therapy (genital focus)

Timeline

• Start date: 2002-06-01
• Completion: 2004-09-01
• First posted: 2002-04-22
• Last updated: 2006-08-18

Locations

1 site across 1 country: United States