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Testosterone in Female Hypoactive Sexual Desire Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140153
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : November 25, 2009
Information provided by:
Beersheva Mental Health Center

Brief Summary:
The success of sildenafil in the treatment of erectile dysfunction has led to efforts to find similar treatments for prevalent disorders of female sexual dysfunction. Daily transdermal testosterone has been shown to improve sexual function in women after oophorectomy (Shifren et al, Transdermal testosterone treatment in women with impaired sexual function after oophorectomy, New England Journal of Medicine, 343; 682-8, 2000). In laboratory measures of sexual arousal, a single application of transdermal testosterone enhanced vaginal blood and increased erotic fantasy in normal volunteer women in the laboratory setting, four hours after application (Tuiten et al, Can sublingual testosterone increase subjective and physiological measures of laboratory-induced sexual arousal?, Arch Gen Psychiatry, 59;465,2002). We therefore planned a study of transdermal testosterone (25mg) marketed as Androgel in female hypoactive sexual desire disorder. Patients are recruited from the sexology clinics at Soroka Hospital and the Beersheva Mental Health Center. They are randomized to Androgel or placebo and given 10 packets and instructed on application to the abdomen and shoulders, four hours before planned intercourse. Patients unable to discuss planned intercourse with their partner are offered psychosexual counseling and those still unable after three sessions are excluded. After one month patients on active Androgel are crossed over to placebo or vice versa. Patients self-rate sexual response after each intercourse using the Brief Index of Sexual Functioning for Women, and Arizona Sexual Experiences Scale (ASEX)-Female and are rated in interview at the end of each month of treatment using the Sexual Function Questionnaire (SFQ-V1). Our prn technique avoids the androgenizing side effects of continuous daily treatment.

Condition or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder Drug: testosterone gel (Androgel) Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Transdermal Testosterone Gel Prn Application for Hypoactive Sexual Desire Disorder in Women: A Controlled Study
Study Start Date : April 2005
Estimated Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Arizona Sexual Experiences Scale (ASEX)
  2. Sexual Function Questionnaire (SFQ-V1)

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

pre-menopausal females, hypoactive sexual disorder, age 21-40, able to plan intercourse with partner -

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140153

Beersheva Mental Health Center
Beersheva, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Study Director: RH Belmaker, MD Beersheva Mental Health Center Identifier: NCT00140153     History of Changes
Other Study ID Numbers: BMHC-3973
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Beersheva Mental Health Center:
female sexuale dysfunction
controlled double-blind

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents