Testosterone in Female Hypoactive Sexual Desire Disorder

This study has been completed.
Information provided by:
Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
First received: August 31, 2005
Last updated: November 23, 2009
Last verified: November 2009
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 Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: testosterone gel (Androgel)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Transdermal Testosterone Gel Prn Application for Hypoactive Sexual Desire Disorder in Women: A Controlled Study

Resource links provided by NLM:

Further study details as provided by Beersheva Mental Health Center:

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

Estimated Enrollment: 20
Study Start Date: April 2005
Estimated Study Completion Date: April 2006
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Ages Eligible for Study:   21 Years to 40 Years
Genders 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:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00140153

Beersheva Mental Health Center
Beersheva, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Study Director: RH Belmaker, MD Beersheva Mental Health Center
  More Information

ClinicalTrials.gov Identifier: NCT00140153     History of Changes
Other Study ID Numbers: BMHC-3973 
Study First Received: August 31, 2005
Last Updated: November 23, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2016