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

NCT00916396 | Unknown

• 1 other identifier: tasmc-09-MB-158-ctil
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoactive Sexual Desire Disorder

Outcome Measures

Primary Outcomes (1)

• blood and urine tests

  beginning of treatment, and after six weeks of treatment.

Study Arms (2)

real drug

ACTIVE COMPARATOR

Drug: Dehydroepiandrosterone

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Dehydroepiandrosterone DRUG

100 mg of DHEA a day (50 mg twice a day) for six weeks

Also known as: DHEA

real drug

placebo DRUG

100 mg of Placebo a day (50 mg twice a day) for six weeks

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Aviv Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 23084789 DERIVED

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Miki Bloch, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 7, 2009
• First Posted: June 9, 2009
• Study Start: June 1, 2005
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

IL (1)