Testosterone in Female Hypoactive Sexual Desire Disorder

NCT00140153 | Completed Phase 3

• 1 other identifier: BMHC-3973
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoactive Sexual Desire Disorder

Keywords

androgel; female sexuale dysfunction; controlled double-blind; testosterone

Outcome Measures

Primary Outcomes (2)

• Arizona Sexual Experiences Scale (ASEX)

• Sexual Function Questionnaire (SFQ-V1)

Interventions

testosterone gel (Androgel) DRUG

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Beersheva Mental Health Center: lead

Study Sites (1)

Beersheva Mental Health Center

Beersheva, Israel

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• RH Belmaker, MD

  Beersheva Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: April 1, 2005
• Study Completion: April 1, 2006
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

IL (1)