Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder

• ClinicalTrials.gov Identifier: NCT00916396
• Recruitment Status: Unknown
• First Posted: June 9, 2009
• Last Update Posted: December 1, 2009
• Sponsor: Tel-Aviv Sourasky Medical Center
• Information provided by: Tel-Aviv Sourasky Medical Center

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Hypoactive Sexual Desire Disorder	Drug: Dehydroepiandrosterone; Drug: placebo	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder: Modulation of Sexual Libido by Androgens and Neurosteroids
• Study Start Date: June 2005
• Estimated Primary Completion Date: January 2011
• Estimated Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: real drug	Drug: Dehydroepiandrosterone; 100 mg of DHEA a day (50 mg twice a day) for six weeks; Other Name: DHEA
Placebo Comparator: placebo	Drug: placebo; 100 mg of Placebo a day (50 mg twice a day) for six weeks

Outcome Measures

Primary Outcome Measures :

1. blood and urine tests [ Time Frame: beginning of treatment, and after six weeks of treatment. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Woman participating in the research will be in the menopausal phase or after it (above a year in postmenopause)aged 65 and below. Man age range will be 18 - 65.

Exclusion Criteria:

• Individuals suffering from a significant systemic illness, hormonal illness, alcoholism, drug abuse, major depression, "Mano/matroagia" or hypogonadism. Additionally, individuals treated with androgens, antidepressant or any other medication which may cause a disorder in sexual desire.
• Man diagnosed as suffering from prostate carcinoma, BHP or will show PSA levels above 2.5 will not be included.
• Woman treated with HRT or suffering from any of the following diseases will not be included: breast carcinoma, ovarian or uterus cancer or with a first grade family history of one of the mentioned.

Contacts and Locations

Locations

Israel

Tel Aviv Aviv Medical Center; Recruiting

Tel Aviv, Israel

Contact: Miki Bloch, MD 972-3-6974707 mikib@tasmc.health.gov.il

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

• Principal Investigator: Miki Bloch, MD; Tel-Aviv Sourasky Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bloch M, Meiboom H, Zaig I, Schreiber S, Abramov L. The use of dehydroepiandrosterone in the treatment of hypoactive sexual desire disorder: a report of gender differences. Eur Neuropsychopharmacol. 2013 Aug;23(8):910-8. doi: 10.1016/j.euroneuro.2012.09.004. Epub 2012 Oct 18.

• Responsible Party: Dr. Miki Bloch, Tel Aviv medical center
• ClinicalTrials.gov Identifier: NCT00916396
• Other Study ID Numbers: tasmc-09-MB-158-ctil
• First Posted: June 9, 2009
• Last Update Posted: December 1, 2009
• Last Verified: November 2009

Additional relevant MeSH terms:

Hypokinesia; Sexual Dysfunctions, Psychological; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Dehydroepiandrosterone; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs