Hypoactive Sexual Desire Disorder Clinical Trial
Official title:
Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study
Verified date | May 2024 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the present study is to understand the neurobiological mechanisms of action underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which desire was not manipulated. In the present project, Dr. Stephanie Cacioppo is manipulating desire through Flibanserin (Addyi) vs. placebo and she will be measuring subjective sexual desire as a manipulation check. The investigators will address this goal using a double-blind randomized outpatient design and determine the pre-post neurobehavioral change in the Flibanserin group and investigate the extent to which Flibanserin normalizes brain activity in premenopausal women with HSDD and the extent to which regional brain activation is associated with changes in symptoms and behavior (as measured with self-report measures of sexual desire and/or eye-tracking movements).
Status | Terminated |
Enrollment | 57 |
Est. completion date | December 21, 2021 |
Est. primary completion date | December 21, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 74 Years |
Eligibility | Inclusion Criteria: - Female - Ages 21-45 or 51-74 - Pre- or Postmenopausal - DSM-5 diagnosis of hypoactive sexual desire disorder (HSDD) - Right-handed Exclusion Criteria: - Male - Pregnant women - Nursing women - Post-menopausal women - Women who report not being able to stop drinking alcohol during the duration of the study - Currently taking psychotropic medication - History of seizures or neurological disorders - Under hormonal therapy - Current or past diagnosis of cancer - Any unstable medical illnesses - Lifetime history of bipolar disorder, schizophrenia, or psychotic disorder - Current or recent (past 3 months) substance abuse or dependence - Current or recent (past 3 months) clinical depression - Currently taking any medications that have/may have unfavorable interactions with Flibanserin |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Bianchi-Demicheli F, Cojan Y, Waber L, Recordon N, Vuilleumier P, Ortigue S. Neural bases of hypoactive sexual desire disorder in women: an event-related FMRI study. J Sex Med. 2011 Sep;8(9):2546-59. doi: 10.1111/j.1743-6109.2011.02376.x. Epub 2011 Jun 30. — View Citation
Bolmont M, Cacioppo JT, Cacioppo S. Love is in the gaze: an eye-tracking study of love and sexual desire. Psychol Sci. 2014 Sep;25(9):1748-56. doi: 10.1177/0956797614539706. Epub 2014 Jul 16. — View Citation
Cacioppo S, Bianchi-Demicheli F, Frum C, Pfaus JG, Lewis JW. The common neural bases between sexual desire and love: a multilevel kernel density fMRI analysis. J Sex Med. 2012 Apr;9(4):1048-54. doi: 10.1111/j.1743-6109.2012.02651.x. Epub 2012 Feb 21. — View Citation
Cacioppo S, Cacioppo JT. Dynamic spatiotemporal brain analyses using high-performance electrical neuroimaging, Part II: A step-by-step tutorial. J Neurosci Methods. 2015 Dec 30;256:184-97. doi: 10.1016/j.jneumeth.2015.09.004. Epub 2015 Sep 10. — View Citation
Cacioppo S, Couto B, Bolmont M, Sedeno L, Frum C, Lewis JW, Manes F, Ibanez A, Cacioppo JT. Selective decision-making deficit in love following damage to the anterior insula. Curr Trends Neurol. 2013;7:15-19. — View Citation
Cacioppo S, Weiss RM, Runesha HB, Cacioppo JT. Dynamic spatiotemporal brain analyses using high performance electrical neuroimaging: theoretical framework and validation. J Neurosci Methods. 2014 Dec 30;238:11-34. doi: 10.1016/j.jneumeth.2014.09.009. Epub 2014 Sep 20. — View Citation
Ortigue S, Bianchi-Demicheli F. The chronoarchitecture of human sexual desire: a high-density electrical mapping study. Neuroimage. 2008 Nov 1;43(2):337-45. doi: 10.1016/j.neuroimage.2008.07.059. Epub 2008 Aug 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EEG Results: Evoked Brain Potentials (Measured Brain Response That is the Direct Result of a Specific Cognitive Event) | Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus). | 8 weeks | |
Secondary | Eye Movement Tracking: Movements to First Saccades | Change from baseline eye movement tracking results at 8 weeks. | 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
Completed |
NCT01432665 -
Lybrido for Female Sexual Dysfunction
|
Phase 2 | |
Terminated |
NCT00551785 -
Surveillance Study of Women Taking Intrinsa®
|
Phase 4 | |
Completed |
NCT03232801 -
A Mindfulness-based Intervention for Older Women With Low Sexual Desire
|
N/A | |
Recruiting |
NCT04179734 -
Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder
|
Phase 4 | |
Completed |
NCT01235754 -
Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
|
Phase 3 | |
Completed |
NCT03287232 -
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
|
Phase 3 | |
Completed |
NCT00384046 -
Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen
|
Phase 3 | |
Completed |
NCT00331123 -
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
|
Phase 3 | |
Recruiting |
NCT04943068 -
A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)
|
Phase 3 | |
Completed |
NCT03463707 -
BP101 for Adults With Female Sexual Dysfunction
|
Phase 3 | |
Completed |
NCT01208038 -
Testosterone Patch's Effects on the Cardiovascular System and Libido
|
Phase 4 | |
Completed |
NCT00657501 -
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
|
Phase 3 | |
Completed |
NCT04336891 -
Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
|
||
Completed |
NCT01382719 -
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
|
Phase 2 | |
Recruiting |
NCT00916396 -
Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder
|
N/A | |
Completed |
NCT00331214 -
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
|
Phase 3 | |
Completed |
NCT00338312 -
Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
|
Phase 3 | |
Completed |
NCT00034021 -
Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction
|
Phase 2 | |
Recruiting |
NCT02968342 -
Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women
|
Phase 4 |