Hypoactive Sexual Desire Disorder Clinical Trial
Official title:
Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder: Modulation of Sexual Libido by Androgens and Neurosteroids
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 study's 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.
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 study's 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. ;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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 | |
Terminated |
NCT02770768 -
Effects of Flibanserin on the Pre- and Post-menopausal Female Brain
|
N/A | |
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 | |
Completed |
NCT00338312 -
Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
|
Phase 3 | |
Completed |
NCT00331214 -
Study of Transdermal Testosterone Patches in Surgically 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 |